Joint PSI, EFSPI & ASA BIOP Webinar: Estimands

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.

Speaker	Biography
John Scott	John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2019 draft Guidance on Interacting with the FDA on Complex Innovative Trial Design, and the ICH E9(R1) expert working group on estimands and sensitivity analyses. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is currently an Editor of the journal, Pharmaceutical Statistics.
Andreas Brandt	Andreas Brandt has been working as a statistical assessor in the Biostatistics and Special Pharmacokinetics unit at BfArM (Federal Institute for Drugs and Medical Devices) since 2010. He is an expert of the Biostatistics Working Party (BSWP) at the European Medicines Agency (EMA). Before joining the BfArM, he was a PhD student and post-doctoral scientist at the German Cancer Research Center (DKFZ), Heidelberg. He holds a diploma in Mathematics (MSc equivalent) and a PhD in Genetic Epidemiology.
Vlad Dragalin	Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QS Technical Excellence and Program Strategy) Advisory Committee. He joined Janssen in 2014 as the Head of the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 35 years of experience in developing the statistical methodology of adaptive designs and with more than 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Expert Working Group. He is a member of PhRMA Clinical Development Workgroup. Vlad is a Fellow of the American Statistical Association and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research.
Evgeny Degtyarev	Evgeny Degtyarev is Global Program Biostatistics Head leading a team of quantitative scientists on CAR-T program in hematology at Novartis. Before joining Novartis in Basel in 2013, Evgeny studied mathematics and economics at the University of Magdeburg in Germany. Since then he has supported several oncology programs with targeted and immunotherapies in different stages of development. He has co-founded and co-leads the industry working group “Estimands in oncology” in Feb 2018 which has been later granted the status of EFSPI/PSI Special Interest Group and ASA Biopharmaceutical Section Scientific Working Group (www.oncoestimand.org).

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