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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.

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.

Urgent Meeting: Medical Statistician Apprenticeship Scheme

The UK government have recently announced that level 7 apprenticeships must be fully funded by the employer from January 2026, for any apprentice over the age of 21. With funding for MSc's at an all time low, and universities courses facing closures, the apprenticeship scheme remains as important as ever, as a tool to encourage new statisticians into our industry. In this dedicated meeting, Valerie Millar (chair of the apprenticeship scheme) will provide full updates on the government changes and seek feedback and ideas from employers, universities and apprentices on how to keep this scheme successfully running for many years to come.

PSI Webinar: Methodology and first results of the iRISE (improving Reproducibility In SciencE) consortium

This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.

One-day Event: Change Management for Moving to R/Open-Source

This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.

PSI Vaccines SIG Webinar: Challenges in Estimating Vaccine Effectiveness Against Progression to Severe Disease

This is a free webinar on Challenges in Estimating Vaccine Effectiveness Against Progression to Severe Disease.

PSI Book Club - The Art of Explanation: How to Communicate with Clarity and Confidence

Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.

PSI Training Course: Pediatric Extrapolation

This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.

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.

EFSPI/PSI Causal Inference SIG Webinar: Instrumental Variable Methods

The webinar is targeted at statisticians working in the pharmaceutical industry, and the objective is to 1) provide a basic understanding of IV methodology including how it relates to causal inference, and 2) present two inspirational pharma-relevant applications.

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

When it comes to R and open-source in the Pharma industry, we would like to point you in the right direction!

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.