PSI Journal Club: Randomization

PSI Book Club: Change: How organisations achieve hard-to-imagine results in uncertain and volatile times

Organizations have to adapt to the transforming landscape of our industry to ensure they continue to be successful in the future. Many of us are feeling the impact of organizational change. By reading John P Kotter’s book we can understand about organizational change and learn how to thrive, rather than just survive, through change. Change, by John P Kotter (and his team), is a summary of all that he has learned over his decades of research and leading change. His book describes why many current approaches to change are inadequate and explains why new solutions need to give people a voice and a role in a new, change-embracing organization. Develop your understanding of organisational change and become empowered to be part of your organisation’s change, by reading Change by John P Kotter and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply knowledge from the book in-between sessions.

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 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. Covering the topics of matching and weighting as well as more advance topics of high dimension propensity scores, multi-valued treatments, double robustness and time-varying scenarios. There will be the opportunity to participate in some hands on practical exercises in R.

AIMS SIG - Open-Source Lunch Bites

Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry.

Making Estimands Work - Practical Approaches with Implementation in Data Standards

This event will discuss the impact of the estimand framework on data flow and data handling for analysis datasets (ADaM). What are the considerations to produce data sets suitable for estimation of estimands and traceability of the occurrence of intercurrent events. This webinar will include tips for best practice, based on the White paper Implementation of ICH E9(R1) Estimands Framework using Data Standards.

PSI/EFSPI Biomarker SIG Webinar: Statistical Methods for ctDNA Data

This webinar will describe what ctDNA is and what the key challenges are for analysing it. We will then summarise and review methods that were published over the last few years for analysing ctDNA data.

PSI Career Young Face-to-Face Event at GSK

The morning will be dedicated to networking opportunities, helping attendees build connections with peers and professionals. In the afternoon, participants can attend a series of talks and workshops, including a career panel featuring speakers from both academia and industry, offering insights into various career paths. There will also be a statistical workshop, as well as the opportunity to learn about and debate some of the hot topics in the world of medical statistics. To wrap up the day, we’re exploring interest in an informal after-work networking event for those keen to continue the conversation.

Joint PSI/EFSPI, Phuse, ASA Safety Working Group Webinar Series: Overview of safety analysis and implementation process of safety surveillance in ongoing studies

The session will have three speakers and a discussant. This session will be the first in a series of webinars around safety in clinical trials. The series is co-organized by PSI, ASA-Biopharm safety working group and PHUSE.

PSI Training Course: Adaptive Designs

This two-afternoon virtual course provides a practical introduction to adaptive clinical trials, focusing on the concepts, applications, and regulatory principles outlined in ICH E20 through real-world examples and case studies.

PSI Vaccines SIG Webinar: Statistical Immune Correlate Analysis of Hemagglutination Inhibition Titers for an mRNA-based Influenza Vaccine

This 1-hour webinar is designed for statisticians with an interest in vaccine development, to learn about the recent application of statistical immune correlate analysis in vaccine development. Specifically, an application of such analyses to evaluate hemagglutination inhibition titers for an influenza vaccine

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

Date: Wednesday 4th November 2026 A careers talk about medical statistics and how it plays a crucial role in developing new medicines. Learn about the field of medical statistics and how it plays a crucial role in developing groundbreaking new medicines, vaccines and healthcare products.

PSI Medical Statistics Student Careers Event 2026

Date: 18 November 2026 This is an excellent opportunity for students to find out more about the field of medical statistics, talk to people from different organisations and make contacts for the future. All students currently studying for a mathematics or statistics-related BSc, MSc or PhD are invited to attend, and we welcome interest from exhibitors too.

Aligning Estimation with the Clinical Question of Interest

This webinar will focus on aligning estimation to estimands. How do different strategies for handling intercurrent events and missing data handling influence the choice of estimation method, with illustration using a case study.

PSI Career Young Virtual Event (Q4 2026)

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 Careers Coaching Series: Peer Support Initiative

This 10-month peer support programme is aimed at professionals with five or more years of experience who are seeking structured development and connection with peers at a similar career stage. Through 5 bi-monthly topics, participants will engage in coach-led presentations, small-group discussions, and regular progress reviews focused on achieving tangible outcomes.

Speaker	Biography
William F. Rosenberger, George Mason University	William F. Rosenberger is Distinguished University Professor at George Mason University. He received his Ph.D. in mathematical statistics from George Washington University in 1992 and since then has spent much of his career developing statistical methodology for randomized clinical trials. He has two books on the subject, Randomization in Clinical Trials: Theory and Practice (Wiley, 2002), which won the Association of American Publishers Award for the best mathematics/statistics book published that year, and has recently been issued in a second edition (Wiley, 2016); and The Theory of Response-Adaptive Randomization in Clinical Trials (Wiley, 2006). In 2017 he was named the 15th Armitage Lecturer at the University of Cambridge, UK. He was elected the North American Editor of the tier-1 biostatistical methodology journal Biometrics, for 2021-2024. In 2024 he was named the 41st Fisher Memorial Lecturer by the Fisher Memorial Trust. He has supervised 20 doctoral students who are now leaders in academia, industry, and government.
Sofia Weigle, Johnson & Johnson	Sofia Weigle is a PhD candidate from Rutgers University who lives in Tewksbury, NJ with her husband, 3 kids and 2 dogs. She has been working at Johnson & Johnson since 2021 where she started with Discovery Statistics. She is currently a Senior Scientist in Manufacturing Statistics where she supports everything from CMC regulatory filings and responses to analytical methods development.
Weng-Kee Wong, UCLA	Professor Wong is a Professor at UCLA since 1990 and over the years, he has done collaborative work in dentistry, environment health science, rheumatology, and various domains in oncology, including in the design and analysis of cancer control and prevention trials for controlling Hepatitis B among Asians, colorectal cancer for Hispanics, and fighting obesity and promotion of minority health at workplace. His main methodology research area is in constructing model-based optimal experimental designs for biostatistical applications. His recent interest is in the application of metaheuristics to tackle challenging problems in designs for toxicology and other areas of statistics. Prof. Wong has received several R01 grant awards from NIH, NSF and private foundations as a principal investigator. He is fellow of the American Statistical Association, the Institute of Mathematical Statistics, the American Association for the Advancement of Science, an elected member of the International Statistical Institute and a full member of the Sigma Xi - The Scientific Research Honor Society. He currently holds a Yushan Scholarship Award from the Taiwan’s Ministry of Education.

Speaker	Biography
William F. Rosenberger, George Mason University	William F. Rosenberger is Distinguished University Professor at George Mason University. He received his Ph.D. in mathematical statistics from George Washington University in 1992 and since then has spent much of his career developing statistical methodology for randomized clinical trials. He has two books on the subject, Randomization in Clinical Trials: Theory and Practice (Wiley, 2002), which won the Association of American Publishers Award for the best mathematics/statistics book published that year, and has recently been issued in a second edition (Wiley, 2016); and The Theory of Response-Adaptive Randomization in Clinical Trials (Wiley, 2006). In 2017 he was named the 15th Armitage Lecturer at the University of Cambridge, UK. He was elected the North American Editor of the tier-1 biostatistical methodology journal Biometrics, for 2021-2024. In 2024 he was named the 41st Fisher Memorial Lecturer by the Fisher Memorial Trust. He has supervised 20 doctoral students who are now leaders in academia, industry, and government.
Sofia Weigle, Johnson & Johnson	Sofia Weigle is a PhD candidate from Rutgers University who lives in Tewksbury, NJ with her husband, 3 kids and 2 dogs. She has been working at Johnson & Johnson since 2021 where she started with Discovery Statistics. She is currently a Senior Scientist in Manufacturing Statistics where she supports everything from CMC regulatory filings and responses to analytical methods development.
Weng-Kee Wong, UCLA	Professor Wong is a Professor at UCLA since 1990 and over the years, he has done collaborative work in dentistry, environment health science, rheumatology, and various domains in oncology, including in the design and analysis of cancer control and prevention trials for controlling Hepatitis B among Asians, colorectal cancer for Hispanics, and fighting obesity and promotion of minority health at workplace. His main methodology research area is in constructing model-based optimal experimental designs for biostatistical applications. His recent interest is in the application of metaheuristics to tackle challenging problems in designs for toxicology and other areas of statistics. Prof. Wong has received several R01 grant awards from NIH, NSF and private foundations as a principal investigator. He is fellow of the American Statistical Association, the Institute of Mathematical Statistics, the American Association for the Advancement of Science, an elected member of the International Statistical Institute and a full member of the Sigma Xi - The Scientific Research Honor Society. He currently holds a Yushan Scholarship Award from the Taiwan’s Ministry of Education.

Speaker	Biography
William F. Rosenberger, George Mason University	William F. Rosenberger is Distinguished University Professor at George Mason University. He received his Ph.D. in mathematical statistics from George Washington University in 1992 and since then has spent much of his career developing statistical methodology for randomized clinical trials. He has two books on the subject, Randomization in Clinical Trials: Theory and Practice (Wiley, 2002), which won the Association of American Publishers Award for the best mathematics/statistics book published that year, and has recently been issued in a second edition (Wiley, 2016); and The Theory of Response-Adaptive Randomization in Clinical Trials (Wiley, 2006). In 2017 he was named the 15th Armitage Lecturer at the University of Cambridge, UK. He was elected the North American Editor of the tier-1 biostatistical methodology journal Biometrics, for 2021-2024. In 2024 he was named the 41st Fisher Memorial Lecturer by the Fisher Memorial Trust. He has supervised 20 doctoral students who are now leaders in academia, industry, and government.
Sofia Weigle, Johnson & Johnson	Sofia Weigle is a PhD candidate from Rutgers University who lives in Tewksbury, NJ with her husband, 3 kids and 2 dogs. She has been working at Johnson & Johnson since 2021 where she started with Discovery Statistics. She is currently a Senior Scientist in Manufacturing Statistics where she supports everything from CMC regulatory filings and responses to analytical methods development.
Weng-Kee Wong, UCLA	Professor Wong is a Professor at UCLA since 1990 and over the years, he has done collaborative work in dentistry, environment health science, rheumatology, and various domains in oncology, including in the design and analysis of cancer control and prevention trials for controlling Hepatitis B among Asians, colorectal cancer for Hispanics, and fighting obesity and promotion of minority health at workplace. His main methodology research area is in constructing model-based optimal experimental designs for biostatistical applications. His recent interest is in the application of metaheuristics to tackle challenging problems in designs for toxicology and other areas of statistics. Prof. Wong has received several R01 grant awards from NIH, NSF and private foundations as a principal investigator. He is fellow of the American Statistical Association, the Institute of Mathematical Statistics, the American Association for the Advancement of Science, an elected member of the International Statistical Institute and a full member of the Sigma Xi - The Scientific Research Honor Society. He currently holds a Yushan Scholarship Award from the Taiwan’s Ministry of Education.

Speaker	Biography
William F. Rosenberger, George Mason University	William F. Rosenberger is Distinguished University Professor at George Mason University. He received his Ph.D. in mathematical statistics from George Washington University in 1992 and since then has spent much of his career developing statistical methodology for randomized clinical trials. He has two books on the subject, Randomization in Clinical Trials: Theory and Practice (Wiley, 2002), which won the Association of American Publishers Award for the best mathematics/statistics book published that year, and has recently been issued in a second edition (Wiley, 2016); and The Theory of Response-Adaptive Randomization in Clinical Trials (Wiley, 2006). In 2017 he was named the 15th Armitage Lecturer at the University of Cambridge, UK. He was elected the North American Editor of the tier-1 biostatistical methodology journal Biometrics, for 2021-2024. In 2024 he was named the 41st Fisher Memorial Lecturer by the Fisher Memorial Trust. He has supervised 20 doctoral students who are now leaders in academia, industry, and government.
Sofia Weigle, Johnson & Johnson	Sofia Weigle is a PhD candidate from Rutgers University who lives in Tewksbury, NJ with her husband, 3 kids and 2 dogs. She has been working at Johnson & Johnson since 2021 where she started with Discovery Statistics. She is currently a Senior Scientist in Manufacturing Statistics where she supports everything from CMC regulatory filings and responses to analytical methods development.
Weng-Kee Wong, UCLA	Professor Wong is a Professor at UCLA since 1990 and over the years, he has done collaborative work in dentistry, environment health science, rheumatology, and various domains in oncology, including in the design and analysis of cancer control and prevention trials for controlling Hepatitis B among Asians, colorectal cancer for Hispanics, and fighting obesity and promotion of minority health at workplace. His main methodology research area is in constructing model-based optimal experimental designs for biostatistical applications. His recent interest is in the application of metaheuristics to tackle challenging problems in designs for toxicology and other areas of statistics. Prof. Wong has received several R01 grant awards from NIH, NSF and private foundations as a principal investigator. He is fellow of the American Statistical Association, the Institute of Mathematical Statistics, the American Association for the Advancement of Science, an elected member of the International Statistical Institute and a full member of the Sigma Xi - The Scientific Research Honor Society. He currently holds a Yushan Scholarship Award from the Taiwan’s Ministry of Education.

Speaker	Biography
William F. Rosenberger, George Mason University	William F. Rosenberger is Distinguished University Professor at George Mason University. He received his Ph.D. in mathematical statistics from George Washington University in 1992 and since then has spent much of his career developing statistical methodology for randomized clinical trials. He has two books on the subject, Randomization in Clinical Trials: Theory and Practice (Wiley, 2002), which won the Association of American Publishers Award for the best mathematics/statistics book published that year, and has recently been issued in a second edition (Wiley, 2016); and The Theory of Response-Adaptive Randomization in Clinical Trials (Wiley, 2006). In 2017 he was named the 15th Armitage Lecturer at the University of Cambridge, UK. He was elected the North American Editor of the tier-1 biostatistical methodology journal Biometrics, for 2021-2024. In 2024 he was named the 41st Fisher Memorial Lecturer by the Fisher Memorial Trust. He has supervised 20 doctoral students who are now leaders in academia, industry, and government.
Sofia Weigle, Johnson & Johnson	Sofia Weigle is a PhD candidate from Rutgers University who lives in Tewksbury, NJ with her husband, 3 kids and 2 dogs. She has been working at Johnson & Johnson since 2021 where she started with Discovery Statistics. She is currently a Senior Scientist in Manufacturing Statistics where she supports everything from CMC regulatory filings and responses to analytical methods development.
Weng-Kee Wong, UCLA	Professor Wong is a Professor at UCLA since 1990 and over the years, he has done collaborative work in dentistry, environment health science, rheumatology, and various domains in oncology, including in the design and analysis of cancer control and prevention trials for controlling Hepatitis B among Asians, colorectal cancer for Hispanics, and fighting obesity and promotion of minority health at workplace. His main methodology research area is in constructing model-based optimal experimental designs for biostatistical applications. His recent interest is in the application of metaheuristics to tackle challenging problems in designs for toxicology and other areas of statistics. Prof. Wong has received several R01 grant awards from NIH, NSF and private foundations as a principal investigator. He is fellow of the American Statistical Association, the Institute of Mathematical Statistics, the American Association for the Advancement of Science, an elected member of the International Statistical Institute and a full member of the Sigma Xi - The Scientific Research Honor Society. He currently holds a Yushan Scholarship Award from the Taiwan’s Ministry of Education.

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