Past PSI Events

Conferences

  • 16 Jun 2024

    2024 PSI Annual Conference

    Dates: Sunday 16th - Wednesday 19th June 2024 The PSI 2024 Conference was held from Sunday 16th to Wednesday 19th June 2024 at Beurs van Berlage in Amsterdam, Netherlands. The Conference program extended over 3 days from Monday to Wednesday. It included a variety of plenary and parallel sessions, as well as breakout discussion sessions, workshops, and a poster session. On the Sunday prior to the conference there were pre-conference course(s). Registration included multiple social events, including a welcome reception on Sunday evening, a networking event on Monday and, last but not least, the conference gala dinner on the Tuesday night. There was plenty of networking with other delegates and sponsors at breaks. Thank you to everyone involved in the conference: speakers, poster presenters, delegates, exhibitors, sponsors and the PSI scientific committee, for contributing to another fantastic event.

  • 11 Jun 2023

    2023 PSI Annual Conference

    The PSI 2023 Conference took place at Novotel Hammersmith, London between the 11th and 14th of June 2023. This year's Conference was record-breaking all round, with 618 delegates listening to more than 120 speakers across 40 sessions! Thank you to everyone involved in the conference: speakers, poster presenters, delegates, exhibitors, sponsors and the PSI scientific committee, for contributing to another fantastic event.

  • 12 Jun 2022

    2022 PSI Annual Conference

    The PSI 2022 Conference took place at Gothia Towers, Gothenburg, Sweden from 12th to 15th June. The conference consisted of a variety of plenary and parallel sessions, as well as breakout discussion sessions, workshops, a poster session and the Annual General Meeting.

  • 21 Jun 2021

    2021 PSI Annual Conference

    The PSI 2021 conference was held online due to the COVID-19 (coronavirus) pandemic. The conference ran over three full days and consisted of a variety of live plenary and parallel sessions, additional on demand content, breakout discussion sessions, workshops, posters and virtual exhibitor stands.

  • 08 Jun 2020

    2020 PSI Annual Conference

    The PSI 2020 conference was cancelled due to the COVID-19 (coronavirus) pandemic. As a replacement, a series of webinars were run.

  • 02 Jun 2019

    2019 PSI Annual Conference

  • 03 Jun 2018

    2018 PSI Annual Conference

    The 2018 PSI Conference held in Amsterdam on the 3-6 June broke more records by being the biggest PSI conference to date, with 391 delegates.

  • 14 May 2017

    2017 PSI Annual Conference

    The 2017 PSI Conference held in London on the 14-17 May was our most successful UK conference to date.

  • 22 May 2016

    2016 PSI Annual Conference

    The 2016 PSI conference took place at The Pullman Hotel, Berlin, between 22 to 25 May 2016. It was the 39th consecutive annual event.

  • 22 May 2016

    A PSI Pre-Conference Training Course

    A PSI Pre-Conference Training Course on Subgroup Analysis Presented by Aaron Dane, Armin Koch, Ilya Lipkovich & Gerd Rosenkranz

  • 10 May 2015

    2015 PSI Annual Conference

    The 2015 PSI Annual Conference "Relevant Applications in a Changing Environment" took place at The Millennium Gloucester Hotel, London, between 10 – 13 May. It was the 38th consecutive annual event and attracted just under 300 delegates and exhibitors.

  • 11 May 2014

    2014 Annual Conference

    The 2014 PSI Annual Conference took place at The Tower Hotel, London, between 11 – 14 May. It was the 37th consecutive annual event and attracted over 300 delegates and exhibitors.

Scientific Meetings

  • 18 Mar 2024

    Joint PSI/EFSPI HTA SIG Webinar: Indirect treatment comparisons - choosing the right tool for the job

    Dates: Monday 26th February | Monday 18th March 2024 This event aims to provide information on the purpose and methods for ITC. The speakers will review and compare different approaches for ITC in both anchored and unanchored case. Both drug regulatory and reimbursement body’s views on using ITC will be discussed. The speakers will offer insights into issues such as marginal and conditional effect, unmeasured confounding and provide case studies to demonstrate the use of ITC methods in practice.

  • 24 Nov 2023

    PSI Scientific Meeting: Master Protocols - Industry, Academic, and Regulatory Perspectives

    This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution.

  • 18 Oct 2023

    PSI Scientific Meeting: Patient-focused drug development

    The meeting will consider the importance of patient-centric input into regulatory and HTA decision-making discussing the latest developments in the field and presenting industry examples.

  • 23 Jan 2023

    PSI Scientific Meeting: Decentralised Clinical Trials

    In this event we will hear from expert speakers on the statistical and operational challenges and considerations of decentralised clinical trials, the promise of digital health data and wearable technology, as well the regulatory perspective to such studies

  • 13 Oct 2022

    PSI Scientific Meeting: Adaptive Designs and their Application

    Join us to here about some hot topics in the area of adaptive designs and associated methods. There will be a mixture of cutting edge methodology and real world applications. Along with the opportunity for plenty of discussion and sharing of ideas and opinions!

  • 17 Sep 2021

    PSI Scientific Meeting: Generating Insights through Modern Applications of Data Visualisation

    This event will offer a practical introduction to modern methods of data visualisation.

  • 04 May 2021

    PSI One-Day Meeting: Missing Data in Clinical Trials - Past, Present and Future

    At this meeting we will present the evolution of missing data approaches, looking at how they have been handled in the past, the current established missing data approaches and the impact of the new ICH E9 R1 addendum on the handling of missing data, focussing in particular on the treatment policy estimand.

  • 29 Apr 2021

    PSI One-Day Meeting: Non-proportional hazards and applications in immuno-oncology

    Hear about potential strategies to handle non-proportional hazards and delayed treatment effects from experts in the field.

  • 02 Mar 2021

    PSI Webinar: Wearable Technologies - Challenges and Opportunities

    Wearable technologies and digital health data offer great opportunities for studying patients functionally in real life settings. Actigraphy, for example, can be used as part of clinical trials to collect continuous movement data, but the frequency of data collection results in dense datasets requiring extensive processing and signal detection. In this webinar, a panel of expert speakers will discuss how such aspects can be addressed to help realize the promise of these technologies.

  • 06 Feb 2020

    PSI New Starters Half-Day Networking Event

    An opportunity to meet statisticians from across the pharmaceutical industry in a relaxed and informal setting. An exciting program of events and a chance to work in small groups on a data analysis challenge. Lunch provided.

  • 29 Oct 2019

    PSI One Day Meeting: Time-to-event and Recurrent Event Endpoints in Clinical Trials

  • 11 Sep 2019

    Impact of AI on Clinical Development

    In association with PSI, UCB and Cytel are delighted to invite you to join a symposium, educating on Artificial Intelligence (AI) approaches and their impact on clinical development.

  • 17 Jul 2019

    PSI One day Scientific meeting: The analysis and reporting of PROs in Clinical Trials

    The PSI Scientific Committee have put together this one day meeting to provide statisticians with introductions to PROs, how to include them in clinical trials, considerations about missing data, appropriate statistical methods to analyse and interpret the data and the perspective of an IQWiG assessor.

  • 24 Jun 2019

    PSI One day Scientific meeting, South West: Designing and Analysing Adaptive Trial Design Studies

    During this meeting we will hear about adaptive sample allocation for phase II/III designs, a new CONSORT extension reporting guideline for adaptive designs, regulatory aspects and case studies.

  • 02 Apr 2019

    PSI Toxicology SIG Workshop 2019

    This 1.5-day workshop will involve approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types.​

  • 28 Mar 2019

    PSI One Day Meeting: New Starters SIG

    This is the inaugural meeting of the recently relaunched New Starters Special Interest Group. The aim of this meeting is to provide a relaxed environment for early career statisticians to network and interact with their peers across the industry.

  • 29 Jan 2019

    PSI One Day Meeting: New Emerging Topics around Estimands and ICH Addendum

    The draft ICH E9 addendum on estimands and sensitivity analysis was released back in July 2017 and (more than 1000) comments are back. All stakeholders are gaining the necessary experience and familiarity with estimands along with the associated challenges and methodologies. The language and thinking behind causal inference is well suited to this area.

  • 18 Sep 2018

    PSI One Day Meeting and Workshop: Real World Evidence: Generalisability of Treatment Comparisons for Decision Making

    RWE data are an increasingly valuable resource in drug development. One area where this data is being used regularly is in the generalisability of treatment comparisons. This event will focus on this topic and more specifically on new advances in indirect comparisons, generalizability approaches for clinical trial data into the real world setting and cross-design approaches combining observational and randomized data.

  • 24 Apr 2018

    PSI Toxicology SIG Workshop 2018

    The Toxicology SIG provides a forum for statisticians working in regulatory and investigative toxicology to discuss issues and interact with one another. This 1.5-day workshop will involve hopefully approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types.

  • 28 Feb 2018

    PSI One Day Meeting: Bayesian Methods for Dose Finding and Biomarkers

  • 28 Nov 2017

    European Statistical Meeting: Latest Trends in Health Technology Assessments

    This 1-day scientific meeting will provide an update on latest trends in HTA, including: the Real-World Evidence Navigator tool created by the IMI GetReal project; the EUnetHTA Joint Action 3 initiative and methodology being researched; introduction to value-based frameworks and estimands in HTA. Patient perspectives in HTA will be discussed including how to involve patients in HTA and latest methods in patient reported outcomes. HTA related methodological considerations will be highlighted including approaches to handle treatment switching in HTA. Industry HTA case studies will also be presented.

  • 22 Nov 2017

    PSI One Day Meeting: Extrapolation

    Use of extrapolation techniques is playing an increasingly important role in the development of new medicines particularly with regard to special populations such as paediatrics and rare diseases. This meeting will include speakers from industry, academia and regulatory (including Rob Hemmings from MHRA).

  • 27 Sep 2017

    PSI One Day Meeting: Estimands – Examples for Statisticians!

    The PSI Scientific Committee have put together this one day meeting to provide Statisticians with real world examples of how Estimands have been defined. Presenters will give their insight into discussions with colleagues, working groups and regulators and there will be plenty of opportunity to ask your questions on defining an Estimand.

  • 19 Jun 2017

    PSI One Day Meeting: Career Young Statisticians

    The aim of this meeting is to provide a relaxed environment for career young statisticians where they can present and discuss various statistical topics and interact/network with other statisticians in similar positions to themselves.

  • 15 Jun 2017

    BBS / PSI One-day Event on Cancer Immunotherapy

    This joint Basel Biometric Society / PSI one day meeting will present an overview of the science and potential statistical challenges across a range of topics covering early and late phases of development, regulatory and health technology assessments.

  • 30 Mar 2017

    Free PSI Scientific Meeting. Translational Statistics: Ideas-Evidence-Innovation-Communication

    Speakers include John Hinde, Claire Brittain, Paul Frewer, Fabio Rigat, Thomas Jaki, Guiyuan Lei and Ricardus Vonk

  • 14 Mar 2017

    Toxicology SIG Workshop 2017

    The Toxicology SIG provides a forum for statisticians working in regulatory and investigative toxicology to discuss issues and interact with one another.

  • 02 Nov 2016

    PSI One Day Meeting: Sample Size Re-estimation – dealing with those known unknowns!

    The aim of this PSI one day meeting is to present an overview of available methods for sample size re-estimation together with several case studies where such methods have been used in late phase clinical trials.

  • 14 Sep 2016

    Time-to-Event and Recurrent Event Endpoints

    This exciting one-day workshop will cover a wide range of statistical aspects relating to event-driven trials. This is a joint event with the BBS (Basel Biometric Section of the Austro-Swiss Region of the IBS);

  • 05 Jul 2016

    The Design and Analysis of N of 1 Trials

    This course will present the latest thinking on n-of-1 trials and cover not only their analysis through SAS®, R® GenStat® and meta-analysis packages but also approaches to design.

  • 17 Jun 2016

    PSI One Day Meeting: Immunology Diseases

    During this one day meeting, PSI aims to cover a wide range of immunology diseases, design considerations and statistical challenges when working in this therapeutic area.160 +

  • 27 Apr 2016

    Use of Simulation in Clinical Trial Design

  • 13 Nov 2015

    PSI Respiratory One Day Meeting

    During this one day meeting, PSI aims to cover a wide range of respiratory diseases and design considerations when working in this therapeutic area. We hope that sharing between different areas; will stimulate interesting discussion and an opportunity to knowledge share.

  • 09 Oct 2015

    PSI Graphics One Day Meeting

    This PSI one day meeting aims to cover a wide variety of areas where graphics can, and are, being used within the pharmaceutical industry and beyond. By sharing and engaging in multiple and varied examples attendees will come away from the meeting with a renewed appreciation of the benefits of graphical representations and ideas of where these tools could prove useful within their own areas of work.

  • 28 Sep 2015

    European Statistical Meeting on Estimands

    Controversy and confusion exist on the definition and selection of appropriate estimands in the clinical trial context. This meeting will provide a forum to hear about the latest developments and discussions on this topic. Speakers include members of the ICH working group as well as representatives from academia, European regulatory bodies and industry. The day will end with a panel discussion including all speakers.

  • 07 Sep 2015

    Advanced Topics in Survival Analysis

    The course assumes familiarity with basic methods for summarising survival data, including estimates of the survivor function and the log rank test.

  • 29 Jun 2015

    Statistical Innovations in Clinical Trials

    London Area Symposium: Statistical Innovations in Clinical Trials at Amgen (Uxbridge) in collaboration with Cytel. Speakers are Peter Colman (UCB) Cyrus Mehta (Cytel), James Wason (MRC Biostatistics Unit, Cambridge), Kevin Carroll (kjcstatistics)

  • 19 Feb 2015

    Estimands Discussion Meeting

    In October 2014 the ICH Steering Committee endorsed a final Concept Paper with the goal of developing new regulatory guidance, suggested to be an Addendum to ICH E9, which promotes harmonised standards on the choice of estimands in clinical trials and an agreed framework for planning, conducting and interpreting sensitivity analyses of clinical trial data. An Expert Working Group sponsored by ICH has been established to further develop the concept and is due to report findings in December 2015. Frank Bretz and Chrissie Fletcher are the EFPIA representatives on the ICH E9(R1) Expert Working Group

  • 05 Nov 2014

    How do Data Monitoring Committees Operate?

    This one day meeting is aimed at people who serve on Data Monitoring Committees, people who organise them, and people involved in preparing statistical reports and safety listings for them. The day will cover the remit and organisation of DMC’s, together with speakers’ personal experiences of the proces

  • 03 Sep 2014

    Prior Elicitation

    This 1-day scientific meeting provides an opportunity to learn about some of the main techniques for incorporating historical data into study analyses using different discounting methods, and for eliciting expert prior information in situations where no or limited historical data are available.

  • 05 Jun 2014

    Communicating Complex Statistical Concepts

    With increased pressures to run smaller, quicker studies that need to deliver more answers than ever before we are tasked with designing innovative studies that can meet these demands but remain statistically sound. This 1-day meeting aims to address how we, as statisticians, can better communicate the underlying complex statistical methodology such that our clinical colleagues better understand the risks and the decisions they will be able to make at the end of the study.

Training Courses

  • 02 Oct 2024

    PSI Training Course: Regulatory Guidelines for Statisticians

    Dates: Wednesday 2nd & Thursday 3rd October 2024 This 2-day course is designed to provide a comprehensive understanding of the regulatory guidelines affecting statisticians in the pharmaceutical industry, including the latest updates in the field. The course will cover key International Council for Harmonisation (ICH) guidelines and other key regional regulatory agency documents.

  • 22 Apr 2024

    PSI Training Course: Introduction to Machine Learning

    Dates: Monday 22nd - Thursday 25th April 2024 This course is aimed at clinical trial statisticians who are new to or with limited experience of machine learning. Attendees will learn about a range of topics in machine learning, including practical sessions in R.

  • 26 Feb 2024

    PSI Pre-Clinical SIG Workshop

    The Pre-Clinical SIG Workshop returns for 2024, bringing you a two half-days event, starting with a course on pre-clinical design of experiments. We will also have speakers on topics such as statistics and genetic toxicology, the new and promising OMARS DOE and ANOVA-type.

  • 29 Jan 2024

    PSI Training Course: R for Clinical Trial Statisticians

    This course consists of 5 x 2 hour training sessions run over 5 weeks. For those who cannot attend the date and time provided, there will be a recording provided and a follow-up 1 hour Q and A session. Participation will provide access to extensive course materials in the form of a “bookdown” site. However, this is designed as a hands-on, interactive course. Both you and the trainers will work entirely within the RStudio Cloud development environment, which will remain accessible between virtual sessions in order to further explore and cement your understanding.

  • 14 Nov 2023

    PSI Training Course: Sample Sizing for Clinical Trials

    This course describes calculations for sample size estimation in the design of clinical trials. It will highlight how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.

  • 09 Oct 2023

    PSI Training Course: Missing Data

    This course will introduce participants to the key concepts and methods relevant for analysing clinical trials when some data are missing.

  • 05 Sep 2023

    PSI Training Course: Propensity Scores - practical application in non-randomised studies

    The course will introduce the topic of propensity scores and the use of external data, with opportunities to participate in some hands-on practical exercises in R.

  • 21 Sep 2022

    PSI Pre-Clinical SIG Workshop 2022

    Meet with colleagues across industry and learn more about Bayesian Methodology and its applications in pre-clinical.

  • 04 Jul 2022

    PSI Training Course: Hybrid Frequentist / Bayesian Power and Bayesian Power in Planning Clinical Trials

    Aimed at Statisticians working on the design of Clinical Trials, participants will learn how to use Expected Power, Average Power, Predicted Power, Probability of Success and Assurance, and Bayesian Power when planning clinical trials.

  • 14 Mar 2022

    PSI Training Course: Simulation of Clinical Trials using Tidyverse

    In this course, we introduce a framework for clinical trial simulations that makes extensive use of the tidyverse collection of R packages.

  • 24 Jan 2022

    PSI Training Course: Use of Historical Data in Clinical Trials: An Evidence Synthesis Approach

    In this short course, we will provide a statistical framework to incorporate external information into a trial. Bayesian Dynamic Borrowing designs based on the meta-analytic predictive (MAP) model will be detailed, and a practice session will be proposed with applications using the R package RBesT.

  • 01 Nov 2021

    PSI Training Course: R for Clinical Trial Statisticians

    R is quickly gaining popularity within the pharmaceutical industry due to it being a very powerful object-orientated language, and is able to produce analyses and high quality graphics. This will be a hands-on interactive course and will utilise the RStudio Cloud development environment.

  • 14 Oct 2021

    PSI Training Course: Repeated Measured and Mixed Models

    A PSI Training Course covering the statistical methods for repeated measures and other clustered data. Course will cover: Conditional models for continuous hierarchical data, Conditional models for continuous longitudinal data, Marginal models (GEE) for continuous longitudinal data & Discrete data.

  • 08 Jun 2021

    PSI Training Course: Data Monitoring Committees (DMCs)

    This course will cover the essentials of DMC set up (roles and responsibilities, DMC charter, practical considerations), as well as discussing DMC case studies and the role of DMCs in adaptive trials and during the pandemic. In addition, there will be an interactive DMC workshop.

  • 17 May 2021

    PSI Training Course: R for SAS Users

    R is quickly gaining popularity within the pharmaceutical industry due to it being a very powerful object-orientated language, and is able to produce analyses and high quality graphics. This will be a hands-on interactive course and will utilise the RStudio Cloud development environment.

  • 03 Mar 2021

    PSI Leadership event: Lunchtime conversation with Chrissie Fletcher & Andy Grieve

    Join this lunchtime event to hear an informal discussion about statistical leadership with Chrissie Fletcher and Andy Grieve.

  • 01 Oct 2020

    Introduction To Industry Training Course 2020

    The ITIT course will take 25 delegates new to the industry on a complete drug development experience from discovery to marketing. They will visit 6 companies to learn about 6 topics from experts in their field. The ITIT course will have 3 sessions in continental Europe and 3 sessions in the UK. The start of the 2020-2021 course will be delayed until face-to-face meetings with up to 30 people are permitted and companies are allowing travel again.

  • 18 Feb 2020

    PSI Training Course - Bayesian Practical Course using R and SAS

    This practical training course will give a deep dive into performing Bayesian analyses in R and SAS. It is aimed at statisticians who need to be able to conduct Bayesian analyses as part of their day to day work. By the end of the course participants will be able to conduct their own analyses.

  • 12 Feb 2020

    A PSI Training Course - Practical Approaches to Designing Adaptive Clinical Trials

    This hands-on course will provide a deep dive into 4 software packages used to design adaptive clinical trials. The course will start by providing a general overview of adaptive designs, explaining the different type of adaptations possible and the benefits of each design. Following this, participants will be given the opportunity to have a go at designing trials in R (using RPACTS), EAST, FACTS, and nQuery.

  • 19 Nov 2019

    A PSI Training Course on ICH for Statisticians

    This course will give an overview of ICH guidelines for all statisticians in the setting of drug development trials and drug approval in the pharmaceutical industry.

  • 22 May 2019

    Estimands and Sensitivity Analysis in Clinical Trials

    In this course we provide an in-depth review of the estimand framework as laid out by the draft ICH E9 addendum and present case studies illustrating the implementation of this framework in clinical trials.

  • 07 Mar 2019

    Network Meta Analysis (NMA) for Statisticians

    This intensive course will cover all basic and advanced aspects of synthesis of evidence from studies comparing competing treatments for the same health condition. By the end of this course participants will have an understanding of the role and potential of network meta-analysis, the principles, steps and statistical methods involved; the biases that can distort indirect comparisons and network meta-analysis.

  • 26 Sep 2018

    Regulatory Interactions for Statisticians

    The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective.

  • 20 Sep 2018

    Statistics Fundamentals of Clinical Trials for Non-Statisticians (or ‘How to speak stats in a day!’)

    This is a 1-day course, aimed to introduce statistics to people who work on Clinical Trials, but who are not Statisticians. No previous knowledge of Statistics is assumed as we start right at the beginning with the basics. Many practical examples are given and the emphasis is on application and understanding rather than the equations and the technical background.

  • 09 May 2018

    PSI Training Course: Multiple Testing in Confirmatory Clinical Trials

    This course will focus on the principles underlying multiple comparison procedures and their applications to confirmatory clinical trials. We will describe simple ways to construct valid multiple tests, and will explore how tests can be incorporated into recycling strategies.

  • 24 Apr 2018

    Health Technology Assessment (HTA)

    This 2-day course will provide an introduction to the methods of health technology assessment.

  • 06 Mar 2018

    A PSI Training Course on Missing Data

    The course will provide participants the opportunity to gain insight into some of the more useful new methodologies for missing data, with a view to being at the service of the real scientific question of interest.

  • 14 Nov 2017

    Statistics Fundamentals for Clinical Trials for Non-Statisticians (or ‘How to speak stats in a day!’)

    This is a 1-day course, aimed to introduce statistics to people who work on Clinical Trials, but who are not Statisticians. No previous knowledge of Statistics is assumed as we start right at the beginning with the basics. Many practical examples are given and the emphasis is on application and understanding rather than the equations and the technical background.

  • 21 Sep 2017

    Improving Influence and Increasing Impact: Essential Skills for Industry Statisticians

    This course will lead participants, in a non-threatening and encouraging atmosphere, through the process of understanding their own strengths and weaknesses and what this means when working as a strategic partner or as part of a larger team. It will include workshops to practice the skills and behaviours discussed.

  • 28 Jun 2017

    Estimating Sample Sizes in Clinical Trials

    The three most important aspects of a clinical trial are: design, design and design. A sample size estimate is just one aspect of a clinical study design. The course describes calculations for sample size estimation in the design of clinical trials. It will be highlighted how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.

  • 01 Mar 2017

    Dose Finding in Drug Development using MCP-Mod

    This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course.

  • 26 Jan 2017

    Health Technology Assessment (HTA) Training Course

    Presented by Mark Sculpher, Neil Hawkins and members of the HTA SIG

  • 08 Nov 2016

    Introduction to Simulation

    The aim of this course is to provide participants an understanding simulation techniques. The 2 day course includes a variety of practical examples and example code will be provided in both SAS and R. Presented by Les Huson

  • 22 May 2016

    A PSI Pre-Conference Training Course

    A PSI Pre-Conference Training Course on Subgroup Analysis Presented by Aaron Dane, Armin Koch, Ilya Lipkovich & Gerd Rosenkranz

  • 08 Mar 2016

    Structured Benefit-Risk Assessment – Methodology and Practice

    The 2 day course includes a practical workshop whereby participants will critically evaluate the benefit-risk balance of medicinal and healthcare product(s) in a robust and transparent manner.

  • 24 Nov 2015

    Advanced Concepts in Adaptive Design

    A PSI Training Course on Advanced Concepts in Adaptive Design.

  • 21 Oct 2015

    Introduction to Simulation

    This course provides an introduction to simulation techniques as applied to problems in the design and analysis of clinical trials.

  • 13 Oct 2015

    Toxicology SIG Workshop

    The Toxicology SIG provides a forum for statisticians working in regulatory and investigative toxicology to discuss issues and interact with one another.​

  • 20 May 2014

    Missing Data

    A PSI Training Course on Missing Data Presented by Mike Kenward (GlaxoSmithKline Professor of Biostatistics) and James Roger (Honorary Professor of Biostatistics) Department of Medical Statistics London School of Hygiene and Tropical Medicine

  • 25 Feb 2014

    Practical Interactions for Statisticians

    This course provides an introduction to practical Bayesian analysis in the clinical trial setting. It is aimed at statisticians who are looking for a practical introductory course and who need to be able to conduct Bayesian analyses as part of their day to day work. The course begins with an introduction to Bayesian analyses using problems common in the clinical trial setting and progresses to the use of Bayesian approaches in Dose Response modelling and Meta-Analysis.

  • 04 Feb 2014

    Introduction to Pharmacokinetics & Bioequivalence

    This course serves as an introduction to pharmacokinetics and bioequivalence. It aims to introduce much of the terminology that is used. It will be most suited to Statisticians or Statistical Programmers who have familiarity with clinical trials but have had limited previous experience with designing or analysing trials with pharmacokinetics or bioequivalence objectives. A basic understanding of ANOVA will be assumed.

Journal Club

  • 12 Sep 2024

    PSI Journal Club Webinar: Subgroup and Covariate Analysis

    Date: Thursday 12th September 2024 Björn Holzhauer and Thomas Jemielita present their recent work on subgroup and covariate analysis. Chaired by Chris Harbron.

  • 09 Apr 2024

    PSI Journal Club: Limitations and Challenges with Mixed Model Repeated Measures (MMRM) Analysis

    Date: Tuesday 9th April 2024 Moses Mwangi and Florian Lasch present their recent work on MMRM, with discussion lead by Geert Molenberghs.

  • 09 Nov 2023

    PSI Journal Club: Bayesian Approaches in Efficacy and Safety

    Please join us to hear Kristian Brock and Ying Yuan present their recent work for our next Journal Club webinar, as sponsored by Wiley.

  • 22 Jun 2023

    PSI Journal Club: Propensity Scores

    Learn more about the different techniques and applications propensity scores and the advantages and disadvantages of different methods.

  • 16 Dec 2022

    PSI Journal Club: Biomarker Adaptive Designs

    The DIA Statistics and Data Science Virtual Journal Club are pleased to announce a joint webinar with the Statisticians in the Pharmaceutical Industry (PSI) journal club. The title is Biomarker Adaptive Designs.

  • 07 Sep 2022

    PSI Journal Club: Estimating Treatment Effects

    Our next journal club features two papers on the topic of “Estimating Treatment Effects”. Please join us to hear Yongming Qu (Eli Lilly) and Solomon Harrar (University of Kentucky) present their recent work.

  • 26 Apr 2022

    PSI Journal Club: Treatment Switching in Clinical Trials

    Our next journal club features two papers on the topic of “Treatment Switching in Clinical Trials”. Please join us to hear Franz König (Medical University of Vienna) and Juliane Manitz (EMD Serono) present their recent work.

  • 06 Jul 2021

    PSI Journal Club: The Use of External Controls in Clinical Trials

    Our next journal club features two papers on the topic of “The Use of External Controls in Clinical Trials”. Please join us to hear Chris Harbron (Roche) and Margaret Gamalo (Pfizer) present their recent work. The webinar will be chaired by Nigel Stallard (Warwick University).

  • 24 Mar 2021

    PSI Journal Club: Survival Analysis

    Our next journal club features two papers on the topic of Survival Analysis. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.

  • 17 Nov 2020

    PSI Journal Club: Bayesian Methods

    Please join us to hear Jingjing Ye (BeiGene) and Amy LaLonde (Eli Lilly) present their recent work. The webinar will be chaired by Bruno Boulanger (PharmaLex).

  • 16 Sep 2020

    PSI Journal Club: Longitudinal Data

    Our next journal club features two papers on the topic of Longitudinal Data, will be held on the 16th September 2020 from 4-5pm BST.

  • 23 Apr 2020

    PSI Journal Club: Progressing Phase II Data into Phase III

    Our next journal club features two papers on the topic of Progressing Phase II Data into Phase III, held on the 23rd April 2020 from 4-5pm BST. Please join us to hear Haolun Shi (Simon Fraser University, Burnaby) and Daniele De Martini (Università degli Studi di Milano‐Bicocca, Milan) present their recent work. The webinar will be chaired by Andy Grieve (UCB).

  • 24 Oct 2019

    The PSI & DIA’s Journal Club: Subgroup Analyses Webinar 24th October 2019, 4pm - 5:00pm (BST)

    Join us in our discussion on Subgroup Analyses at 4pm (BST) on Thursday 24th October.

  • 11 Jul 2019

    The RSS & PSI’s Journal Club: Survival Analysis

    Join us in our discussion on survival analysis method with focus on the application of two Bayesian methods for time to event data at 4pm (BST) on Thursday 11 July.

  • 15 May 2019

    PSI Journal Club: PhD Webinar

    Our next journal club is the inaugural PhD webinar, where we will share 4 topics with you from 4 PhD students. Our format will be slightly changed, with each student presenting for 10 minutes, followed by 5 minutes of discussion.

  • 24 Jan 2019

    PSI Journal Club: Missing Data

    Our next journal club, held jointly with the DIA, features two papers on the topic of Statistical Considerations for Innovative Designs in Clinical Trials. Please join us to hear Jason Yuan and Xiangmin Zhang present their recent work.

  • 11 Dec 2018

    PSI and DIA Journal Club: Statistical Considerations for Innovative Designs in Clinical Trials

    Our next journal club, held jointly with the DIA, features two papers on the topic of Statistical Considerations for Innovative Designs in Clinical Trials. Please join us to hear Jason Yuan and Xiangmin Zhang present their recent work.

  • 24 Sep 2018

    PSI/RSS Journal Club: Meta-Analysis

    Our next journal club, held jointly with the RSS, features two papers on the topic of Meta-Analysis.

  • 12 Jul 2018

    PSI Journal Club Webinar: Bayesian Methods

    Our next journal club features two papers on the topic of Bayesian Methods. Please join us to hear Qingzhao Yu (Louisiana State University) and Margaret Gamalo‐Siebers (Eli Lilly & Co) present their recent work.

  • 26 Apr 2018

    PSI Journal Club Webinar: Modelling and Simulation

  • 12 Jul 2017

    Journal Club - Adaptive Signature Design

    At this joint PSI/RSS journal club webinar, held on 12th July 2017, we heard two excellent presentations on the topic of Adaptive Signature Designs, followed by a fascinating discussion led by Dr Richard Simon, who founded the original methodology.

  • 22 Mar 2017

    Journal Club - Biomarkers

    Our first journal club of the year will featured two papers from Pharmaceutical Statistics on the topic of Biomarkers. The event will be held on Wednesday 22nd March, 15:00 to 16:30 (UK time) For more details please see the journal club homepage.

  • 23 Nov 2016

    Journal Club - Analysing Adverse Event Data

    Our third journal club of the year featured two papers from this summer's Special Interest Issue of Pharmaceutical Statistics on the topic of Analysing Adverse Event Data. Arthur Allignol (Ulm University, Germany) and Tanja Proctor (University of Heidelberg, Germany) presented their work. The event was held on 23rd November, 13:30 (UK time)

  • 06 Jul 2016

    Journal Club - Estimands

    Our second event of the year was a joint event with the RSS on the topic of estimands. The event was held on the 6th July 2016, with speakers Alan Phillips and Peter Diggle presenting their work.

  • 10 Mar 2016

    Journal Club - Poisson/Negative Binomial Modelling

    Our first event of the year was on the topic of Poisson/Negative Binomial Modelling and the different techniques for dealing with missing data. The event took place on March 10th, with speakers Richard Kay and Mouna Akacha presenting their work.

  • 15 Dec 2015

    Journal Club - Decision Rules

    Our last event of 2015, sponsored by Wiley, was held in mid-December 2015, on the topic of Decision Rules. We were pleased to co-ordinate with the DIA again for the last event of the year.

  • 15 Oct 2015

    Journal Club - Missing Data

    Our third event of the year was on the topic of Missing Data. Speakers Oliver Keene and Bohdana Ratitch presented their work published in Pharmaceutical Statistics.

  • 16 Sep 2015

    Journal Club - Simulation and Hypothesis Testing

    Our second event of the year was held in mid-September 2015 on the separate topics of Simulation and Hypothesis Testing. Speakers Andrew Grieve and Anne Benoit presented their work published in Pharmaceutical Statistics.

  • 31 May 2015

    Journal Club - Adaptive Designs

    The first event of 2015 for PSI Pharmaceutical Statistics Journal Club was a joint event with the RSS. The event, sponsored by Wiley and Quintiles, was on adaptive designs and two papers published in Series C of the RSS journal, and Pharmaceutical Statistics, respectively, were presented.

  • 25 Nov 2014

    Journal Club - HTA and Safety Analyses

    Our last event of 2014 was on HTA and Safety analyses. We were please to welcome speakers David Ohlssen and Chrissie Fletcher to discuss their respective papers.

  • 17 Jul 2014

    Journal Club - Hot Topics

    For this "Hot Topics" event, Sara Hughes joined us to discuss data anonymisation, and Kert Viele discussed his work on the use of historical controls.

  • 01 Apr 2014

    Journal Club - Combination Therapies

    Our first event of 2014 was a joint event with the RSS, with speakers Ying Yuan and Michael Sweeting.

  • 12 Dec 2013

    Journal Club - Extreme Value Modelling

    For our final event of 2013 we welcomed Harry Southworth and Janet Heffernan to discuss their two papers on Extreme Value Modelling.

  • 29 Oct 2013

    Journal Club - Sample Size Re-Estimation Techniques

    Daniel Wachtlin and Andrew Jones presented at our joint event with the DIA.

  • 01 Aug 2013

    Journal Club - Papers Chosen by You!!

    Following a survey of the Journal Club audience, the authors of the two papers with the most votes joined us to present their work. Craig Mallinckrodt presented his work on missing data in longitudinal trials and Scott Andersen presented on mixed effects modelling for repeated measures data.

  • 16 Apr 2013

    Journal Club - Survival Analysis

    For our first joint event with the RSS, Abdus Wahed and Nicola Schmitt joined us to present their work on survival analysis.

  • 06 Dec 2012

    Journal Club - Modelling in Drug Development

    For the last event of 2012, Simon Kirby and Kayode Ogungbenro joined us to present their work on modelling in drug development.

  • 27 Sep 2012

    Journal Club - PSI’s Special Interest Groups (SIGs)

    For this special edition, we invited members from the PSI Special Interest Groups (SIGs), to present their work. Helena Geys from the toxicology SIG presented on the statistical methods used in toxicology studies, and Martin Jenkins from the biomarker SIG, presented a statistician's perspective of biomarkers in drug development.

  • 12 Jun 2012

    Journal Club - Decision Making at Interims and DMCs (Joint DIA Event)

    For this joint event with the DIA, Andreas Sashegyi and Sara Hughes presented their work on decision making at interims and DMCs.

  • 18 Apr 2012

    Journal Club - Meta-Analyses in Clinical Trials

    Speakers Steven Julious and Christy Chuang-Stein joined us to present their work on meta-analyses.

  • 13 Dec 2011

    Journal Club - Publications from the Pharmaceutical Industry

    James Matcham and Michael O'Kelly joined us to discuss reporting and publication in the pharmaceutical industry.

  • 21 Jul 2011

    Journal Club - Early Phase Clinical Trials

    Timothy Montague and Ileana Baldi joined us present their work on early phase clinical trials.

  • 05 Apr 2011

    Journal Club - Multiregional Trials (Joint DIA Event)

    For our joint event with the DIA, Paul Gallo presented his work on the consistency of treatment effects in multiregional trials, and James Hung presented on some of the considerations needed in the design and analysis of multi-regional trials.

  • 27 Oct 2010

    Journal Club - Survival Analysis

    Richard Kay joined us to present on assessing evaluation time bias, and Gui-shuang Ying presented on prediction of event times via the Weibull distribution.

  • 10 Jun 2010

    Journal Club - Missing Data

    Alan Phillips and Mohamed Alosh presented their recently published work on missing data.

  • 24 Mar 2010

    Journal Club - Bayesian Methods

    Richard Nixon presented a case study utilising simulations for a Bayesian rheumatoid arthritis trial, and Les Huson joined us to present on Bayesian methodology for a logistic dose-response curve.

  • 01 Dec 2009

    Journal Club Launch

    For our launch, John Whitehead presented his paper, "Action following the discovery of a global association between the whole genome and adverse event risk in a clinical drug-development programme", and Kevin Carroll presented on sample size ("Back to basics: explaining sample size in outcome trials, are statisticians doing a thorough job?").

Webinars

  • 07 Aug 2024

    PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations

    Date: Wednesday 7th August 2024 This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.

  • 02 Jul 2024

    PSI EIWG Webinar: Estimands framework in action, the Alzheimer's disease case

    Date: Tuesday 2nd July 2024 The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.

  • 06 Jun 2024

    Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium

    Date: Thursday 6th June 2024 We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.

  • 29 May 2024

    PSI Webinar: Surrogacy

    Date: Wednesday 29th May 2024 This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.

  • 15 May 2024

    PSI Webinar: Drug Development in Women's Health

    Date: Wednesday 15th May 2024 The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.

  • 25 Apr 2024

    Joint PSI/EFSPI Vaccine SIG Webinar: Statistical and Mechanistic Models for Correlates of Protection

    Date: Thursday 25th April 2024 This webinar will explore two different approaches to Correlates of Protection in vaccine development.

  • 17 Apr 2024

    PSI Webinar: Open Source Software - is it really a free-for-all?

    Date: Wednesday 17th April 2024 Talks from the speakers will cover the use of R in a programming community, submitted to regulators using R, and also programming beyond R in C++ and Julia.

  • 11 Apr 2024

    PSI Webinar: Navigating HTA and Patient Access with Insights from Indirect Treatment Comparisons

    Date: Thursday 11th April 2024 Talks from speakers will cover an introduction to HTA and indirect comparisons for value assessment before focusing in more specifically on topics related to the use of indirect treatment comparisons for patient access.

  • 26 Mar 2024

    Joint PSI/EFSPI Pre-Clinical SIG Webinar: Mixed-Level OMARS Designs for Quantitative and Categorical Factors: Theory and Application

    Date: Tuesday 26th March 2024 Professor Goos will present a framework on mixed level OMARS designs and will illustrate the proposed approach using a case study from a medical-chemical example.

  • 13 Dec 2023

    PSI VisSIG Wonderful Wednesday Webinar Series (2023)

    Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

  • 12 Dec 2023

    PSI Careers Lunch & Learn: Is it AI? Can you spot the fake?

    In a world buzzing with artificial intelligence, can you distinguish between what's AI-generated and what's not? The session promises to showcase machine-generated content, challenging your perceptions, and luring you into the fascinating world of AI technology.

  • 07 Dec 2023

    PSI HTA SIG Webinar: Estimands, PICOs and Co. - Are we losing or gaining in translation?

    Over the past years, areas of clinical development and patient access / health technology assessment (HTA) have moved closer together. However, both areas differ in how they approach their respective research or policy questions. While the estimand framework is being the focus in clinical development, HTA is being viewed through the lens of the PICO framework. This webinar brings together Antonio Remiro-Azocar, Robert Hemmings and Nicholas Latimer, who are renowned experts in the respective fields. They will provide an introduction to these three concepts, illustrated with examples.

  • 06 Dec 2023

    PSI Webinar(s): Causal inference in Clinical Trials

    Over the course of two sessions, a panel of 8 esteemed speakers will give an introduction to the topic, followed by a presentation of case studies & interactive panel discussion.

  • 16 Nov 2023

    PSI Biomarkers European SIG Webinar: A promising adaptive biomarker-based design strategy for early phase and machine learning as an enabler of precision medicine!

    In this webinar, you will get to know how an innovative adaptive design can increase the probability of success of your early phase clinical trial as well as hear the latest and greatest of the Machine Learning workstream from the Biomarkers ESIG.

  • 26 Oct 2023

    PSI Vaccine SIG Webinar: A Vaccine Statistician’s Journey in Designing and Analyzing Monoclonal Antibody Studies

    Our speaker will share her experience in extending/innovating methodology and concepts developed in vaccine statistics to the analyses of pre-efficacy and efficacy trials of monoclonal antibodies.

  • 24 Oct 2023

    PSI Pre-Clinical SIG Webinar: Adjusting Experimental & Statistical Approaches throughout Preclinical development pathways

    PD Dr. Tölch will present a framework to foster efficient evidence generation in preclinical experiments and will illustrate the proposed approach using examples from various projects. This will be followed by Q&A.

  • 05 Oct 2023

    PSI Launch & Lifecycle SIG Webinar: Do you want to stay single? Considerations on single arm trials in the post-regulatory space

    We will present the most frequently asked questions in the post-marketing space, the reasons why SATs are not able to address these questions, and how statisticians might reasonably influence decision makers to consider alternatives.

  • 03 Oct 2023

    PSI Webinar: Application of Bayesian Methods in Confirmatory Trials

    This webinar consists of three presentations providing examples of where Bayesian methods have been used within confirmatory settings.

  • 12 Sep 2023

    PSI Careers Lunch & Learn: ChatGPT & Beyond

    A panel discussion on AI advances and uses in medical statistics and programming within the pharmaceutical industry with its opportunities and challenges.

  • 11 Sep 2023

    PSI Webinar: NextGen is now! How to inspire the future workforce of pharmaceutical statistics

    In this webinar we will be showing you how you can inspire NextGen and help shape the future workforce of pharmaceutical statistics.

  • 27 Jun 2023

    PSI Pre-Clinical SIG Webinar: An investigation to improve nonlinear mixed-effects approach for EC50 estimation based on multi-donor dose-response data

    Drs Qiu and Wenren will present their investigations on EC50 estimation based on multi-donor dose-response data via different approaches.

  • 17 May 2023

    PSI Webinar: Discover Data Science

    In this webinar, we explore the application of data science methods in medicine, taking in a range of perspectives from the pharmaceutical industry through to academia.

  • 30 Mar 2023

    PSI EIWG Webinar: Proposing Estimands from Different Perspectives

    The webinar will build on the concepts and case studies previously discussed. A case study in heart failure will be presented from the perspective of multiple stakeholders.

  • 17 Mar 2023

    PSI Careers Lunch & Learn: Modern Leaders: Remote not Distant

    In the upcoming event - "Modern Leaders: Remote not Distant" - we will be discussing the need for a conscious evolution of leadership styles as remote working becomes commonplace.

  • 14 Mar 2023

    PSI Pre-Clinical SIG Webinar: End-user Tool for Immunogenicity Cut-points Calculation

    This webinar will discuss the development of an adaptable yet fully automated end-user tool that allows a harmonized and regulatory compliant calculation and evaluation of immunogenicity cut-points. This will be followed by Q&A.

  • 19 Jan 2023

    PSI Biomarkers SIG Webinar: Biomarkers in Clinical Development

    In this webinar, you will learn more about recent advances in biomarker-based designs, machine learning for biomarkers and data repositories for biomarker use cases.

  • 12 Dec 2022

    PSI Careers Lunch & Learn: Pharma-ly Fortunes

    The upcoming event - "Pharma-ly Fortunes" - will involve playing along to a Family Fortunes style survey - it promises to be a fun but informative session where we hear from our experienced panel on wide ranging career-related topics. We may even debunk some popular myths!

  • 01 Dec 2022

    PSI Webinar: Covariate Adjustment - Considerations and Examples

    The webinar will cover the theory and practice behind covariate adjustment in clinical trials with the opportunity to discuss the latest developments and recommendations in the field. The talks will inform on the methodology and will also provide a practical guide and examples with focus on real world application.

  • 14 Nov 2022

    Joint PSI & EFSPI HTA SIG Webinar: Statistics in EU HTA - PICOs, Estimands & More

    The EU regulation on Health Technology Assessment (HTA) is coming into force from 2025! But why should pharmaceutical statisticians care? Join our webinar to find out more…

  • 25 Oct 2022

    PSI Webinar Series: Showcasing R use in Pharma

    Talks in these webinars will cover general frameworks for app development, regulatory submissions using R and case studies of using R Shiny in both operational and methodological settings.

  • 20 Oct 2022

    PSI Vaccines SIG Webinar: Assessing Population Level Vaccine Effectiveness Under Different Study Designs

    This presentation provides a brief description of the herd protective effects of the oral cholera vaccines, as an example, that have been evaluated for herd protection in various study settings, leveraging the geographic information system (GIS) tools for analyses.

  • 04 Oct 2022

    PSI Pre-Clinical SIG Webinar: Therioepistemology - Rethinking how we conduct animal-based experimentation

    In this webinar we will explore Therioepistemology: the study of how knowledge is gained from animal research, and outline six questions that help critically evaluate animal-based biomedical research from a therioepistemological perspective.

  • 21 Jun 2022

    PSI Pre-Clinical SIG Webinar: Assay Qualification by Linear Mixed Model: Confidence, Prediction & Tolerance Intervals

    Dr Francq will discuss the need for analytical methods to deliver unbiased and precise results and talk in detail on confidence, prediction and tolerance intervals work in linear mixed models and the interpretation of statistical results. This will be followed by Q&A.

  • 18 May 2022

    PSI VIS SIG Webinar: Collaborative & Exploratory Data Analysis

    In this talk, you will learn how to quickly explore your data in the web browser and how to create, collaborate and share interactive visualisations with others.

  • 28 Apr 2022

    PSI Webinar: Novel composite estimands and their analysis

    In this event, speakers will present different composite estimand strategies for clinical trials, the analyses that target these estimands, and regulatory considerations for clinical trials with composite estimands and endpoints. A discussant will reflect on the presentations.

  • 12 Apr 2022

    PSI Pre-Clinical SIG Webinar: Optimal experimental design in preclinical dose-response studies

    In this webinar we give an overview over the statistical optimal design approach in this context. We show how optimal designs can be constructed, covering mainly all-purpose designs (D-optimality) but also more specific designs (c-optimality). We introduce a graphical representation. Next, we show how these concepts can be extended to trials aiming to estimate the interaction between two different substances given simultaneously.

  • 23 Mar 2022

    PSI Webinar: Statistical Challenges in Gene Therapy Trials

    Clinical trials for gene therapies pose many challenges. This webinar covers a number of these including case studies.

  • 22 Mar 2022

    PSI RWD SIG Webinar: Real-World Evidence Submission - a Case Study in Lung Transplantation

    The FDA Real-World Evidence (RWE) Framework was published in Dec. 2018, shedding some light on how Real-World Data (RWD) can be used to support regulatory decision making. Recently, tacrolimus was approved for Lung transplantation based solely on RWE. Three stakeholders – the sponsor, RWD vendor and FDA - will share their experiences of the submission and approval process.

  • 26 Jan 2022

    PSI Webinar: Tipping Point Analyses - Introduction & Case Studies

    What is a tipping point analysis, and how is one performed? What are the different approaches for continuous, binary and time to event data? Our speakers will present and discuss some practical examples.

  • 12 Jan 2022

    PSI VisSIG Wonderful Wednesday Webinar Series

    This is a good opportunity to develop your knowledge by thinking through a practical example, practicing how to apply graphics principles, and developing your coding skills.

  • 02 Dec 2021

    PSI Vaccine & COVID-19 SIGs Joint Webinar: Statistics, Vaccine Development, and the COVID-19 Crisis

    The first talk will be about "Introduction to Statistical Methods and Challenges in Vaccine Development" by Ivan Chan and the second talk will be about "Vaccine quintet. Statistical issues in the design and analysis of five vaccine programmes" by Stephen Senn.

  • 19 Nov 2021

    PSI EIWG Webinar: Estimands from trial planning to publication in medical journals: The ETHOS trial

    Building on the previous webinar series we will present a refresher on the key elements of the estimand framework and use the ETHOS study.

  • 17 Nov 2021

    PSI Sub Group SIG Webinar: Modern approaches to subgroup identification

    Overview and Recent methodological Advances for Identifying Treatment Effect Heterogeneity in Clinical Trials.

  • 28 Oct 2021

    PSI Vaccine SIG Webinar: Evaluating the Durability of Protection for COVID-19 Vaccines

    Here, we show how to estimate potentially time-varying placebo-controlled vaccine efficacy in this type of staggered vaccination of participants.

  • 21 Oct 2021

    Joint PSI, EFSPI & ASA BIOP Webinar: Complex Innovative Designs

    Complex Innovative Designs: overview and case studies from FDA pilot program and considerations on master protocols.

  • 29 Sep 2021

    PSI Leading for Impact Workshop

    Whatever your current challenge(s) at work, this workshop will explore what's holding you back, and how barriers can be removed in order to progress and achieve.

  • 06 Jul 2021

    Adapting to an online world: PSI's journey through 2020/2021 and AGM

    This year's Annual General Meeting will focus on how PSI has navigated the challenges of the past year and adapted to the new online world, as well as how we plan to embrace a new Board structure and new opportunities as we move forward.

  • 29 Jun 2021

    PSI Pre-Clinical SIG Webinar: Update from the Carcinogenicity working group

    This presentation will give some background regarding the ‘Carcinogenicity Statistics Discussion Group’. The talk will review the history of the group, outline the current status, and give an overview of the types of topics discussed.

  • 01 Jun 2021

    PSI EIWG Webinar: Estimands in Oncology - How and Why

    A year on after the final ICH E9 estimands addendum was published, we bring estimands to life. Members of the Estimands in Oncology special interest group will describe how the estimand framework provides a common language to describe the diversity of patient journeys and why it is important to address the right question in clinical trials.

  • 25 May 2021

    PSI Webinar: Oncology Ted Style Talks (with interaction)

    The format of this event will include Ted Talks by all of our speakers with the opportunity for us to have a discussion together after each of the presentations.

  • 19 May 2021

    PSI VisSIG Webinar: Grammar of Graphics - theory to implementation

    In this talk we'll introduce the Grammar of Graphics, which allows you to compose graphs by combining independent components, and the implementation of this theory in R -- the ggplot2 package.

  • 28 Apr 2021

    PSI VisSIG Webinar: Rapid Insights to Data

    The field of data visualization is the intersection of data journalism, statistics, graphic design, computer science, neuroscience, and cognitive psychology. We will focus on the latter two fields of data visualization as it relates to data visualization: neuroscience and cognitive psychology.

  • 14 Apr 2021

    PSI VisSIG Wonderful Wednesdays

    Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

  • 16 Mar 2021

    PSI ToxSIG Webinar: Beyond the looking glass - Interpreting animal welfare & behaviour by monitoring & assessing mice activity data

    Analysing continuously collected locomotive activity data to interpret mice welfare and behaviour.

  • 02 Mar 2021

    PSI Webinar: Wearable Technologies - Challenges and Opportunities

    Wearable technologies and digital health data offer great opportunities for studying patients functionally in real life settings. Actigraphy, for example, can be used as part of clinical trials to collect continuous movement data, but the frequency of data collection results in dense datasets requiring extensive processing and signal detection. In this webinar, a panel of expert speakers will discuss how such aspects can be addressed to help realize the promise of these technologies.

  • 19 Jan 2021

    PSI EIWG Webinar: PIONEERing estimands in Clinical Research (Session 2)

    Bringing estimands to life through a real case study. Members of the estimands Implementation Working Group (EIWG) will describe the background and study objectives, intercurrent events of interest and chosen estimands in the PIONEER study.

  • 12 Jan 2021

    PSI EIWG Webinar: PIONEERing estimands in Clinical Research (Session 1)

    Bringing estimands to life through a real case study. Members of the estimands Implementation Working Group (EIWG) will describe the background and study objectives, intercurrent events of interest and chosen estimands in the PIONEER study.

  • 10 Dec 2020

    PSI Vaccine SIG Webinar: Some considerations on developing COVID-19 Vaccines

    Statistical Observations on SARS-CoV-2 & Crisis Vaccine Clinical Testing. Scott Patterson, Bo Fu, Ya Meng, Fabrice Bailleux, Josh Chen.

  • 08 Dec 2020

    PSI Webinar: Innovative approaches in the development of pediatric medicines

    Do you want to learn more about innovative approaches for the development of pediatric medicines? Then join this PSI webinar on December 8. We have organized an exciting webinar with very knowledgeable speakers who will share their thoughts, ideas and experiences, including case studies, on a range of issues relating to historical data, Bayesian methodology, and partial and full extrapolation approaches in the context of developing pediatric medicines.

  • 02 Dec 2020

    PSI Webinar: Risk Based Monitoring & QTL's

    Since the introductio of ICH-E6 R2 Addendum sponsors must introduce formal Quality Risk Management and define Quality Tolerance Limits to their clnical development programs. This webinar will cover an introduction to those concepts, recent developments and examples of how companies are defining QTL's in practice.

  • 01 Dec 2020

    PSI ToxSIG Webinar: Combining Sexes

    The webinar will provide a general introduction to the topic of combining sexes for statistical analysis in Toxicology. It will also discuss guideline recommendations pertaining to this topic.

  • 25 Nov 2020

    PSI ToxSIG Webinar: Biomarkers in Toxicology

    In this Webinar focus will be given to safety biomarkers. Statistical issues in data science that nonclinical statisticians might encounter along the way will be discussed.

  • 05 Nov 2020

    Joint PSI, EFSPI & ASA BIOP Webinar: Estimands

    PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.

  • 15 Oct 2020

    PSI Vaccine SIG Webinar: Statistical Topics on COVID-19 Therapeutic and Vaccine Clinical Trials

    We are delighted to be joined by Frank Harrell who will present 'Sequential Bayesian Designs for Rapid Learning in COVID-19 Therapeutic Trials'; and also by Dean Follmann, who will present on 'Statistical Aspects of COVID-19 Vaccine Trials'. Join us for this insightful and highly topical webinar.

  • 13 Oct 2020

    PSI Webinar: Patient preference studies

    In this webinar you will hear an introduction to what a patient preference study is as well as an overview of where this type of study can inform regulatory decision making. This will be followed by 2 examples looking at potential approaches to eliciting patient preference.

  • 23 Sep 2020

    PSI Webinar: Master protocols - theory, application and regulatory considerations

    For this webinar, PSI brings together experts on master protocols from the pharmaceutical industry, academia, and regulatory agencies.

  • 03 Sep 2020

    PSI Webinar: Using visualisation to help make decisions

    This webinar will feature presentations from 3 speakers on the topic of Using Visualisations to Help Make Decisions.

  • 15 Jul 2020

    PSI ToxSIG Webinar: Good statistical practices to tackle the lack of reproducibility in preclinical research

    In this webinar we will explain the how to understand the sequences of issues and how to fix it in order to drastically improve the replicability of the results. Through example the presentation will cover concepts such as OFAT vs DoE, p-values and Bayesian statistics and Power vs Assurance as easy opportunities to improve robustness of decisions.

  • 28 Apr 2020

    PSI Webinar: Chosen or Forced - How to manage working from home.

    Given the current situation, pretty much everyone is working remotely from home. Some people are used to working remotely either on a regular or full-time basis this, whilst for many this is a new experience. Remote working, whether chosen or forced, has pros and cons for the company, manager and the statistician.

  • 23 Apr 2020

    PSI Webinar: How can PSI, “a community dedicated to leading and promoting the use of statistics within the healthcare industries for the benefit of patients”, help you be more successful in your career?

    Have you ever wondered what it takes to be successful as a statistician or data scientist in the healthcare/pharma industry and what can give you the extra edge to develop your career? Come and listen to these industry leaders views on how to be successful and the advantages of being part of the PSI community.

  • 31 Mar 2020

    PSI ToxSIG Webinar: Label-free Classification of Ciliated Cells using Deep Learning.

    Using deep learning to review flow cytometry images to determining whether cells are ciliated.

  • 10 Mar 2020

    PSI Webinar - Statistical Operations Research

    This webinar will address operational issues of paramount importance within the healthcare industry with a view to using statistics for the benefit of patients. In attending this webinar, you'll hear more about work being conducted to address some operational issues we face in the health care industries e.g. patient recruitment, drug supply and meeting NHS 18 week targets.

  • 14 Jan 2020

    A PSI ToxSIG webinar - Big Data, Data Science, AI and other buzzwords: What does the Data-Driven Hype mean for Pharmaceutical Analytics?

    The last 15 years has seen a massive shift in the role of data and analytics, driven by the increased hype around big data, data science, machine learning and AI. This presents both challenges and opportunities for analytic teams. This webinar will strip back the hype to look at what these buzzwords really mean, and talk about the impact this is having on the role, remit and operating model of analytic teams in the life sciences industry.

  • 10 Dec 2019

    PSI Webinar - Main statistical approaches for quantitative decision-making in drug development

    We performed a survey among pharmaceutical companies, targeting people with different profiles (statisticians, non-statisticians and decision-makers) working at different stages of the clinical development (study level, development level or portfolio level).

  • 03 Dec 2019

    PSI Webinar - Overview and awareness about quantitative decision-making in drug development

    Quantitative methods to support decision-making in clinical drug development already exist, but may be unknown or unused by pharmaceutical companies.

  • 18 Nov 2019

    PSI Scientific Committee Webinar - Longitudinal modelling: Time to take the next step?

    Longitudinal data, i.e. data that arises from repeated observations of the variable over a period of time, has long been put forward as one way to improve to the efficiency of drug development. However, even though there is a rich statistical methodology for longitudinal data, there is no full, wholehearted uptake of these methods in pharmaceutical statistics..

  • 15 Oct 2019

    PSI Scientific Committee Webinar: Statistical Challenges in Analytical Comparability and Biosimilarity Assessment

  • 02 Oct 2019

    PSI Webinar: Effective Insight Communication

  • 04 Jul 2019

    PSI Webinar: Adaptive design: updated draft FDA guidance and its implications

    In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.

  • 18 Jun 2019

    PSI Toxicology SIG Webinar "Pig-A Assay":

    The in vivo Pig-a gene mutation assay is based on the endogenous X-linked Pig-a gene (phosphatidylinositol N-acetylglucosaminyltransferase, subunit A).

  • 08 May 2019

    Webinar: MCP-Mod – Theory, Implementation and Extensions

    MCP-Mod (Multiple Comparisons & Modelling) is a popular statistical methodology for model-based design and analysis of dose finding studies. This webinar will describe the theory behind MCP-Mod (plus extensions), and how to implement it within available software. Pantelis Vlachos (Cytel) will provide a brief introduction to the methodology and illustrate the MCP-MoD capabilities in EAST 6.5. Saswati Saha (Inserm, Aix-Marseille University) will discuss new variations and alternatives to MCP-Mod and show how to implement them in R. Neal Thomas (Pfizer) will present further technical details of MCP-Mod by evaluating the method using results from least squares linear model theory.

  • 12 Mar 2019

    PSI Webinar: Statistical Engagement with Commercial Activities

  • 19 Feb 2019

    PSI Toxicology SIG Webinar - Data Quality and Reproducibility in Preclinical Research

    Malcolm Macleod will discuss issues of research waste; of replication; and of how these issues might be harnessed to improve research.

  • 21 Jan 2019

    PSI Webinar: HTA Submissions in the UK

    There is a simple equation for access in the UK: Access = Reimbursement + Uptake. Yet, whilst a simple and logical approach, each component is challenging to achieve. This webinar focuses on the National Reimbursement side: the National Institute for Health and Care Excellence (NICE) - who they are, what is involved in the Health Technology Appraisal (HTA) assessment, how they make decisions.

  • 19 Dec 2018

    PSI Webinar: How to use prior knowledge and still give new data a chance?

    The paper to be presented appeared earlier this year in Pharmaceutical Statistics (Weber, Hemmings, Koch, 17, 329-341) and is motivated by the opportunities and challenges for using Bayesian methods with informative priors to support drug development and licencing when only a small pool of patients is available, as in the case of rare diseases and paediatric population.

  • 11 Dec 2018

    How Well do Toxicology Studies Predict Clinical Safety Outcome? – A Translational Safety Big Data Analysis

    Published in: Regulatory Toxicology and Pharmacology 96 (2018) 94–105; https://doi.org/10.1016/j.yrtph.2018.04.018)

  • 29 Nov 2018

    PSI Webinar: Avoiding Pitfalls in Supervised/Unsupervised Learning

    As the availability of big data increases and statisticians assist with predicting outcomes or understanding patterns in an ever-wider variety of scenarios then supervised and unsupervised learning methods become increasing called upon. Such machine learning algorithms offer the opportunity to understand potential predictors or clusters amongst large datasets, but are also subject to the risks of overfitting or over-interpretation. This Webinar seeks to introduce ideas and share experiences in this field.

  • 20 Nov 2018

    EFSPI/PSI Webinar: Do you understand the patient point of view on benefit-risk tradeoffs? Introduction and case studies of stated preference elicitation methods

    This webinar proposes a short primer on stated preference methods and how they can be used to explore the patient preferences for specific drug profiles that are currently available or may be developed in the near future. The theory will be then discussed as applied to two case studies using quantitative preference methods.

  • 18 Sep 2018

    PSI Toxicology SIG Webinar: Strengths, Weaknesses, Opportunities and Threats to the Pre-Clinical Statistician

  • 19 Jun 2018

    PSI Toxicology SIG Webinar

    Ludwig A. Hothorn will be presenting on recent developments of statistics in toxicology - using R.

  • 08 May 2018

    PSI Webinar: Patient Reported Outcomes (PROs) - Clinically Meaningful Interpretation

  • 18 Apr 2018

    PSI Webinar: Basket, Umbrella and Platform trials - Experiences and practical considerations

  • 17 Apr 2018

    PSI Toxicology SIG Webinar

  • 22 Mar 2018

    PSI Webinar: What’s the big deal with big data and will it have a big impact on me?

  • 13 Mar 2018

    PSI/EFSPI Webinar: Quantitative benefit-risk assessment using MultiCriteria Decision Analysis (MCDA) and its extensions: practical application

  • 06 Mar 2018

    PSI Webinar: HTA submissions in Germany, what do statisticians need to know to be successful with their GBA dossiers – Part Three

  • 20 Feb 2018

    PSI Webinar: Integrating transcriptomics into early safety screening

  • 31 Jan 2018

    PSI Webinar: HTA submissions in Germany, what do statisticians need to know to be successful with their GBA dossiers – Part Two

  • 23 Jan 2018

    PSI Webinar: HTA submissions in Germany, what do statisticians need to know to be successful with their GBA dossiers – Part One

  • 12 Dec 2017

    PSI Toxicology SIG Webinar

    This talk introduces a procedure to choose an optimal sparse sampling scheme and sampling time points using non-compartmental methods but which can be applied to further settings beyond this. We discuss how robust designs can be obtained and we apply and evaluate the approach to a range of scenarios to give an example of how it may be implemented.

  • 17 Nov 2017

    EFSPI/PSI Webinar: Anonymising Clinical Data

    The intent of this webinar is to describe what is involved in anonymising clinical data, and present the different methods and approaches available for anonymisation including an introduction to residual risk assessment.

  • 02 Nov 2017

    PSI Webinar: Causal Inference

  • 30 Oct 2017

    EFPSI/EFPIA Webinar: New draft ICH E9 addendum on Estimands and Sensitivity Analysis

  • 24 Oct 2017

    PSI Webinar: Patient Preferences – a webinar with Kevin Marsh presented by the Benefit-Risk SIG

  • 28 Sep 2017

    EFSPI/PSI Webinar: Spotlight on the Integrated Data Analysis SIG

    EFSPI together with PSI will organise a webinar on September 28th on Spotlight on the Integrated Data Analysis SIG

  • 26 Sep 2017

    PSI Webinar: Measuring Patient and Physician Benefit–Risk Preferences in Antipsychotic Clinical Trials

  • 19 Sep 2017

    PSI Webinar: Statistics and the Ames Test

    The bacterial reverse mutation assay (or the Ames test) has been in use in its present form for over 40 years. It is arguably the most successful in vitro test, used by hundreds of laboratories worldwide, on thousands of substances. The test aims to identify substances that can produce genetic damage and may lead to cancer in exposed individuals or to inherited mutation in offspring to cancer.

  • 12 Jul 2017

    Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle: PREFER – an IMI Project

    In our 1-hour webinar on the 12 of July 2017 (4:30pm CET, 3:30pm BST, 10:30am EST) we will have a presentation by Conny Berlin and Rachael DiSantostefano

  • 21 Jun 2017

    PSI Webinar: Data Sharing and Data Privacy - what every statistician needs to know

    The intent of this webinar is to provide an outline to pharmaceutical statisticians of key issues and concepts everyone dealing with and sharing patient level data should be aware of.

  • 13 Jun 2017

    Patient Engagement in Clinical Trials Webinar

    Following on from the successful and thought-provoking presentation at last year’s PSI conference by Paul Wicks from PatientsLikeMe, this webinar will continue to explore the ways in which patients are influencing the design of new clinical trials.

  • 04 May 2017

    Personalised Medicine: Statistics for Companion Diagnostics

    This webinar will introduce and examine some of the considerations required for statisticians working in the field of companion diagnostics and will include information from an FDA (CDRH) speaker and perspectives/ case-studies from representatives from both a pharmaceutical company and a diagnostic company.

  • 09 Feb 2017

    Structured Benefit–Risk Assessment Webinar

    Please join our webinar. We'll have 2 presentations from widely known speakers: The emerging and merging fields of benefit-risk and health technology assessments. The webinar occurs twice - please register for one of the following dates: 1st webinar: 2017 February 9, 5pm CET (4pm GMT) 2nd webinar: 2017 February 14, 5pm CET (4pm GMT)

  • 16 Nov 2016

    PSI Scientific Committee Webinar: Rare Diseases: Regulatory and Study Design Considerations

    Registration is free to attend! Talks from John Scott (Deputy Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research) and Lisa Hampson (Lecturer in Statistics at Lancaster University)

  • 15 Sep 2016

    Second Membership Town Hall: PSI/RSS merger

    Calling all PSI members to register for the upcoming debate regarding the proposed PSI/RSS merger. Hear the arguments for and against the proposal and have the opportunity to ask questions of representatives for each campaign and the RSS.

  • 12 Jul 2016

    Membership Town Hall: PSI/RSS merger

  • 09 May 2016

    PSI Scientific Committee Webinar: Surrogate Endpoints

  • 05 Feb 2016

    Discussion on the Potential Merger With The Royal Statistical Society

    The BoD is in discussions with the Royal Statistical Society about a possible union.

  • 01 Feb 2016

    Discussion on the Potential Merger With The Royal Statistical Society

    The BoD is in discussions with the Royal Statistical Society about a possible union.

  • 16 Jul 2015

    PSI Webinar: Drug Development Beyond the FDA/EMA

    Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.

  • 18 Jun 2015

    PSI Scientific Committee Webinar: Drug Development beyond the FDA/EMA – Opportunities and Challenges in Asia Pacific Development Pathways

    The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link. Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.

  • 16 Oct 2014

    Heart Failure Trials and Recurrent Events

    PSI Scientific Committee Webinar: Heart Failure Trials: Novel Estimands and Methodologies to Evaluate Therapies based on the Totality of Evidence

  • 11 Mar 2014

    Trials and Errors in Clinical Trials

    This webinar aims to take a practical approach to some of the trials and errors seen in Clinical Trials. The webinar will go through some real life examples of where trials and statistical analyses may not have gone as expected! As well as covering some of the errors often seen by the MHRA whilst reviewing submissions

Careers Meetings

  • 17 Sep 2024

    PSI Career Young Virtual Event (Q3 2024)

    Date: Tuesday 17th September 2024 This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

  • 25 Jun 2024

    PSI Career Young Virtual Event (Q2 2024)

    This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

  • 19 Mar 2024

    PSI Career Young Virtual Event (Q1 2024)

    This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

  • 20 Feb 2024

    PSI Mentoring 2024

    Date: Ongoing 6 month cycle beginning late April/early May 2024 Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.

  • 12 Dec 2023

    PSI Careers Lunch & Learn: Is it AI? Can you spot the fake?

    In a world buzzing with artificial intelligence, can you distinguish between what's AI-generated and what's not? The session promises to showcase machine-generated content, challenging your perceptions, and luring you into the fascinating world of AI technology.

  • 05 Dec 2023

    PSI Career Young Virtual Meet (Q4 2023)

    This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

  • 29 Nov 2023

    PSI Medical Statistics Careers Event

    This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.

  • 01 Nov 2023

    PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics

    A careers talk about medical statistics and how it plays a crucial role in developing new medicines

  • 23 Oct 2023

    PSI Book Club

    The next book we are reading is "The 7 Habits of Highly Effective People" by Stephen R. Covey. This is a classic in the personal development genre.

  • 20 Sep 2023

    PSI Career Young Virtual Meet (Q3 2023)

    This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

  • 12 Sep 2023

    PSI Careers Lunch & Learn: ChatGPT & Beyond

    A panel discussion on AI advances and uses in medical statistics and programming within the pharmaceutical industry with its opportunities and challenges.

  • 11 Sep 2023

    PSI Webinar: NextGen is now! How to inspire the future workforce of pharmaceutical statistics

    In this webinar we will be showing you how you can inspire NextGen and help shape the future workforce of pharmaceutical statistics.

  • 06 Jun 2023

    PSI Career Young Virtual Meet (Q2 2023)

    An informal event starting with a short talk and then going into breakout rooms to connect with others from the industry. Aimed at those who have recently joined the industry looking to expand their network.

  • 20 Mar 2023

    PSI Book Club

    Welcome to PSI's book club! We will be reading/discussing non-technical books relevant to our roles. Participants will be split into smaller groups to network with each other and practice exercises.

  • 17 Mar 2023

    PSI Careers Lunch & Learn: Modern Leaders: Remote not Distant

    In the upcoming event - "Modern Leaders: Remote not Distant" - we will be discussing the need for a conscious evolution of leadership styles as remote working becomes commonplace.

  • 16 Mar 2023

    PSI Careers Medical Statistician Apprenticeship - Overview and Q&A with University Providers

    This webinar is an opportunity for potential employers to learn more about the new Medical Statistics Apprenticeship.

  • 07 Mar 2023

    PSI Career Young Virtual Meet (Q1 2023)

    This session will be the chance to hear about the experiences of those across the industry, who are also young in their career, discuss your own experiences and to develop connections. Aimed at those who have recently joined the industry looking to expand their network.

  • 02 Jan 2023

    PSI Mentoring

    Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry. Mentors and mentees will be matched based on experience, personal goals and the sector they work in (unless otherwise requested) so you can be assured that we will aim to tailor the experience to your needs.

  • 12 Dec 2022

    PSI Careers Lunch & Learn: Pharma-ly Fortunes

    The upcoming event - "Pharma-ly Fortunes" - will involve playing along to a Family Fortunes style survey - it promises to be a fun but informative session where we hear from our experienced panel on wide ranging career-related topics. We may even debunk some popular myths!

  • 07 Dec 2022

    PSI Medical Statistics Careers Event

    Our annual PSI Medical Statistics Careers Event, will be held in person at GSK House in Brentford, London on Wednesday 7th December 2022, and will feature live presentations from new starters, a panel discussion with industry representatives, and an exhibition session.

  • 29 Nov 2022

    PSI Career Young Virtual Meet (Quarter 4)

    Aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

  • 09 Nov 2022

    PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics

    In just 1 hour, learn about the field of medical statistics and how it plays a crucial role in developing ground-breaking new medicines, vaccines and healthcare products.

  • 13 Sep 2022

    PSI Careers - Lunch & Learn: Relaunchers

    The upcoming event - "Relaunchers" - will explore the benefits and challenges that come with making a career change or taking a career break.

  • 06 Sep 2022

    PSI Career Young Virtual Meet (Quarter 3)

    Aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

  • 01 Aug 2022

    PSI Book Club

    PSI are running a book club! We will be reading and discussing non-technical books which are relevant to our roles.

  • 28 Jun 2022

    PSI Career Young Virtual Meet

    Aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

  • 29 Mar 2022

    PSI Careers - Lunch & Learn: The Floating Ladder

    This upcoming event - "The Floating Ladder" - will delve into whether the traditional career ladder is still relevant or whether you can build your own?

  • 02 Mar 2022

    PSI Medical Statistics Careers Event

    Our annual PSI Medical Statistics Careers Event, will be held online on Wednesday 2nd March 2022. The event will include a live online panel discussion and a virtual exhibition session.

  • 09 Feb 2022

    PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics

    In just 1 hour, learn about the field of medical statistics and how it plays a crucial role in developing ground-breaking new medicines, vaccines and healthcare products.

  • 10 Nov 2021

    PSI Careers - MED MathS

    In just 1 hour, learn about the field of medical statistics and how it plays a crucial role in developing ground-breaking new medicines, vaccines and healthcare products.

  • 21 Oct 2021

    PSI Careers - Lunch & Learn: Imposter Syndrome Session

    Learn from others in the PSI Community who also associate with Imposter Syndrome. They will discuss the topic, give their own personal views and experiences and provide tips to beat it.

  • 29 Sep 2021

    PSI Leading for Impact Workshop

    Whatever your current challenge(s) at work, this workshop will explore what's holding you back, and how barriers can be removed in order to progress and achieve.

  • 27 Sep 2021

    PSI Book Club

    PSI are starting a book club! We will be reading/discussing non-technical books relevant to our roles. Participants will be split into smaller groups to network with each other and practice exercises.

  • 02 Aug 2021

    PSI Mentoring

    Are you a member of PSI looking to further your career - why not sign up as a mentee? You can expand your network and learn from more senior colleagues in the industry.

  • 03 Mar 2021

    PSI Medical Statistics Careers Event

    Our annual PSI Medical Statistics Careers Event, will be held online using the Career Fair Plus app on Wednesday 3rd March 2021. The event will include a live online panel discussion and a virtual exhibition session.

  • 04 Mar 2020

    Medical Statistics Careers Event 2020

    Our annual PSI Medical Statistics Careers Event, will be held at the De Montfort University in Leicester on Wednesday 4th March 2020.

  • 05 Nov 2019

    Maths Meets Medicine 2019

    The Careers and Academic Liaison Committee (CALC) will be hosting their fourth Maths Meets Medicine event this year at the University of Reading. The event provides the opportunity for KS4 students to come and learn about how...

  • 05 Nov 2018

    Maths Meets Medicine 2018

    The Careers and Academic Liaison Committee (CALC) will be hosting their third Maths Meets Medicine event this year at the University of Reading.

  • 12 Oct 2018

    Bucks Skills Show 2018

    The Bucks Skills Show 2018 is an event for young people to explore careers, discover different industry sectors and work out how to achieve their ambitions.

  • 28 Feb 2018

    Medical Statistics Taster Day 2018

    Our annual careers event, Medical Statistics Taster Day, will be held at the University of Leicester on Wednesday 28th February 2018.

  • 30 Jun 2017

    YSS Statistical Showcase 2017

    This year's event will be held on Friday 30th June, 10am - 7pm, near to the RSS headquarters in Erroll Street, London.

  • 16 Mar 2017

    Schools Event 2017: Maths Meets Medicine, Bath

    Students aged 14-15 will be selected from schools in the regions close to the events to take part in a number of interactive and fun statistics-related workshops, which aim to complement and extend the statistics concepts being taught at KS4 and KS5 levels.

  • 13 Mar 2017

    Schools Event 2017: Maths Meets Medicine, Guildford

    Students aged 14-15 will be selected from schools in the regions close to the events to take part in a number of interactive and fun statistics-related workshops, which aim to complement and extend the statistics concepts being taught at KS4 and KS5 levels.

  • 22 Feb 2017

    PSI Careers Event 2017

    The next PSI Careers Event will be held at the University of Reading on Wednesday 22nd February 2017. MSc students, as well as final year BSc and PhD students will be invited to attend.

  • 01 Jun 2016

    Schools Event 2016

    The Careers and Academic Liaison Committee (CALC) are planning a Schools Event, to be hosted at the University of Reading summer 2016. Date to be confirmed

  • 25 May 2016

    Updated: Berlin Careers Seminar

    As part of the PSI conference in Berlin this year, we will be hosting an interactive careers seminar for students local to the Berlin area.

  • 18 Apr 2016

    SMi’s 8th Annual Adaptive Designs in Clinical Trials

    The event is designed to highlight an array of topics, including adaptive designs within the context of a development programme, Bayesian analysis in adaptive design, biomarker-driven trials, opportunities of adaptive enrichment designs in the era of precision medicine, and much more!

  • 03 Feb 2016

    Careers Fair 2016

    The Careers and Academic Liaison Committee (CALC) are planning the annual Careers Fair Event on Wednesday 3rd February 2016, to be hosted at the University of Reading.

  • 19 Feb 2014

    Success at the PSI Careers Event 2014

    On the 19th February 2014, CALC ran the fourth annual PSI careers event. Fifteen different companies and organisations descended on the University of Sheffield, along with approximately 90 BSc, MSc and PhD students from across the country for a half-day event which consisted of a mix of presentations, newly created workshops, and time for the students to talk to the different companies.

Upcoming Events

Joint PSI/EFSPI Pre-Clinical SIG Webinar: Efficient R&D: SVEM and Advanced DOE in Preclinical Toxicity Testing

Date: Tuesday 8th October 2024 This 1-hour webinar will be an opportunity to hear how JMP have been influential in the toxicity testing of an oncology formulation in a pre-clinical setting. At the end of the presentation there will also be the opportunity to ask questions.

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

Date: The Second Wednesday of every Month Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

Joint PSI/EFSPI Small Populations & RWD SIG Webinar: Harnessing Real-World Data (RWD) in clinical trials for small populations and rare diseases

Date: Thursday 17th October 2024 In this webinar we will review the range of statistical methodologies used to harness the potential of Real-World Data (RWD) in clinical development, particularly in the context of rare diseases and small populations like paediatrics. The session will include theoretical understanding and practical case studies, with a special focus on Bayesian methods and causal inference.

PSI Webinar: Hierarchical composite endpoints in clinical trials: challenges & opportunities

Date: Wednesday 23rd October 2024 In this event, we’ll start with a general introduction to hierarchical composite endpoints and an overview of common analysis methods including win ratio, win odds, and net benefit. Then, the practical considerations will be illustrated through case studies from clinical trials in heart failure and chronic kidney disease. We conclude with a discussion and a Q&A.

PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics

Date: Wednesday 6th November 2024 A careers talk about medical statistics and how it plays a crucial role in developing new medicines

Joint PSI/EFSPI Causal Inference SIG Webinar: Opportunities in applying a causal inference framework during the analysis of an RCT

Date: Tuesday 19th November 2024 This webinar will discuss opportunities in applying causal inference methodology during the analysis of RCT data.

PSI Training Course: Introduction to Bayesian Methods

Dates: Module 1 - Wednesday 20th November Module 2 - Tuesday 26th November Module 3 - Thursday 28th November This interactive and hands on online course, aimed at beginner Bayesians who have little or no experience in Bayesian statistics, is split into 3 modules. Module 1 introduces Bayesian concepts and looks at how Bayes has been used recently in the Pharmaceutical Industry, and participants will undertake their own data collection exercise in order to analyse a simple Bayesian trial. Module 2 takes a look at the concepts of Bayesian statistics and key terminology and provides a chance to analyse some data using a simple Bayesian approach. Module 3 takes a further look at the use of Bayesian statistics in drug development and regulatory requirements and digs deeper into analysis issues.

PSI Medical Statistics Student Careers Event 2024

Date: 20 October 2024 This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.

PSI Vaccines SIG Webinar: Statistical designs for assessment of vaccine safety in pregnancy

Date: Wednesday 20th November 2024 This is a webinar on the design of studies to assess safety of vaccines administered in pregnancy.

Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies

Date: Re-scheduled to Tuesday 26th November 2024 Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.

PSI Career Young Virtual Event (Q4 2024)

Date: Tuesday 10th December 2024 This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Introduction to Industry Training (ITIT) Course - 2024/2025

Date: October 2024 - July 2025 An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

Latest Jobs

Senior Medical Statistician & Statistical Programmer

An exciting opportunity has arisen for a Senior Medical Statistician & Statistical Programmer to join the UKCRC fully registered Derby Clinical Trials Support Unit (Derby CTSU).

Statistics Director

To provide expert statistical and strategic support to asset development programs in GSK Vaccines pipeline.

Unique PhD Graduate Rotation Program - Virtual Analytics Network

Novartis recently established a Virtual Analytics Network in the UK and we are currently recruiting PhD graduates to join this exciting group!