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We are a community dedicated to leading and promoting the use of statistics within the healthcare industry for the benefit of patients.
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Upcoming Events
PSI Introduction to Industry Training (ITIT) Course - 2025/2026
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.
PSI Estimand Online Training (4 Day Workshop)
This is an interactive online training workshop providing an in-depth review of the estimand framework as laid out by ICH E9(R1) addendum with inputs from estimand experts, case studies, quizzes and opportunity for discussions. You will develop an estimand in a therapeutic area of interest to your company. In an online break-out room, you will join a series of team discussions to implement the estimand framework in a case study, aligning estimands, design, conduct, analysis, (assumptions + sensitivity analyses) to the clinical objective and therapeutic setting.
Dissolution Testing: Time for Statistical (r)Evolution
Webinar dedicated to the topic of dissolution of oral solid dosage forms; opportunity to hear from statisticians working in the CMC field, with open question and answers. In addition, the CMC Statistical Network Europe special interest group will discuss advocacy opportunities, have your say to contribute to the future direction.
Pre-Clinical SIG: AI in Medicinal Products
Initially a brief introduction to AI will be given, followed by a presentation of various applications in medicinal product lifecycle. Several aspects will be discussed including performance, theoretical and practical conditions and also regulatory guidelines.
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
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: Dose-finding in Oncology
Who is this event intended for? Statisticians with an interest understanding dose-finding in oncology. What is the benefit of attending? Learn about the state of oncology dose finding, particularly in light of current FDA guidance.
PSI Book Club Webinar: Atomic Habits - The Science of Getting Your Act Together
The book club’s usual focus is to read and discuss professional development books. In this short format event you can more easily develop you career without the commitment of reading the whole book - simply listen to the 1-hour long podcast before joining the interactive session on 21 May.
PSI Career Young Virtual Event (Q2 2025)
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 Career Young Virtual Event (Q3 2025)
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 Career Young Virtual Event (Q4 2025)
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Special Interest Groups
AI and ML
For clinical research statisticians, where specifically are AI & ML useful – considering regulatory requirements.
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.
Causal Inference
Apply advances in causal inference methodology to address industry applications in RCT’s, while taking into account the framework of ICH, e.g. E9(R1), as well as guidelines from health authorities...
CMC Statistical Network Europe
Chemistry, Manufacturing and Control Statisticians, working in Europe for pharmaceutical companies and CROs active in R&D, and we seek to collaborate and exchange in any precompetitive topic of our field.
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.
Patient-Focused Drug Development
The purpose of the PFDD SIG is to connect statisticians in pharmaceutical industry roles who work on progressing the inclusion of patient-reported outcomes (PROs) and clinical outcome assessments (COAs) across all phases of drug development process to share their knowledge and also lead statistical thinking and methods to solve common statistical challenges of use of COAs in drug development.
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.
Software Engineering
Welcome to the home page of openstatsware, a.k.a. the Software Engineering special interest group! Our primary goals are to: Collaborate to engineer selected R-packages and Develop best practices for engineering high-quality statistical software.
Treatment Effect Heterogeneity
Treatment Effect Heterogeneity 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.
Visualisation
Effective visualisation of data should belong to the core skills of statisticians as it represents an essential tool in exploring data as well as explaining data.
Statisticians in the Pharmaceutical Industry Executive Office:
St James House | Vicar Lane | Sheffield | S1 2EX | UK
St James House | Vicar Lane | Sheffield | S1 2EX | UK
E: admin@psiweb.org | T: +44 (0)1625469086