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Upcoming Events

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

PSI Biomarkers 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.

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.

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.

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.

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.

Special Interest Groups

AIMS

The Application and Implementation of Methodologies in Statistics (AIMS)

Benefit-Risk

The Benefit-Risk SIG was set up at the start of 2012 to help support those involved in this fast evolving area.

Biomarkers

The PSI / EFSPI Biomarkers Special Interest Group has been formed with the aim of developing knowledge and opinions within the statisticians about biomarker usage and the related statistical and study design techniques that are involved.

COVID-19

Providing a forum for sharing experiences of statistical and methodological issues relating to clinical trials impacted by COVID-19, clinical trials investigating new treatments for COVID-19 and diagnostic/antibody tests for COVID-19

CSM/QTL

The CSM/QTL SIG is a joint collaboration including PSI, ASA BIOP & EFSPI providing a forum to discuss strategies and methodology with other interested parties in Centralised Statistical Monitoring and Quality Tolerance Limits

Data Science

Bridging Data Science knowledge and expertise across various groups and functions within the pharmaceutical industry to increase collaboration, awareness, knowledge sharing and enhance drug development. We’ll encourage the development of new statistical and machine learning methods and approaches as well as in novel applications of the well-established methods.

Data Sharing

Sharing experiences and challenges of external patient level data sharing with particular focus on data privacy and anonymization processes.

Decision Making

The Quantitative Decision-making Special Interest Group (QDM SIG) was formed in October 2017. It is a group of statisticians from industry and academia, with experience and interests in statistical methods for quantitative decision-making in drug development.

Historical Data

What is the state of the art regarding approaches to incorporate historical data into the formal design and analysis of clinical trials, Which statistical methods should we use to make historical and current data comparable, What are the regulatory requirements necessary for the acceptance of historical data in drug approval?

HTA

The purpose of the Healthcare Technology Assessment SIG is to provide statisticians working in the Pharmaceutical Industry engaged in Health Technology Assessments, and others in related fields of research...

Launch & Lifecycle

Providing a platform for statisticians from sponsors and CROs to working in the launch and lifecycle management (including traditional medical affairs area,

Neuroscience-Estimands

This SIG will connect the following two topics: general biostatistics Neuroscience community, and working groups on estimands & other topics in Neuroscience.

Oncology-Estimands

The draft addendum of the ICH E9 guideline on Statistical Principles for Clinical Trials was released in August 2017 and introduced an estimand framework. In February 2018, Evgeny Degtyarev from Novartis and Kaspar Rufibach from Roche started an informal working group to discuss how to implement the draft addendum in oncological clinical trials.

Pre-clinical

To provide a forum to discuss the statistical issues involved in Regulatory and Investigative Toxicology.

Randomisation

Our passion is to change the way randomisation is considered and performed in clinical trials.

Regulatory

The regulatory SIG co-ordinates regulatory activities across the European Pharmaceutical Statistical community and to engage with European Regulatory statisticians.

RWD

A special interest group to increase collaboration and enhance awareness of strategies and methodologies applied in the utilization of Real World Data in the pharmaceutical industry.

Small Populations

The SIG “Small populations” provides a forum for identifying and discussing statistical methodology related to clinical development of treatments in small populations, and for sharing experiences.

Subgroup Analysis

Subgroup analysis is routinely conducted in drug development, in various settings; one key aspect is the regulatory requirement to demonstrate consistency of treatment effect across a pre-defined set of subgroups (e.g., ICHE5, E9, E17).

Vaccines

Creating a professional platform for statisticians in the Pharmaceutical industry, Regulatory agencies and Public Health organizations working on the research and development of vaccines to understand how best to apply methodologies.