Date: Thursday 12th December 2024 Time: 16:00-17:00 GMT | 17:00-18:00 CET | 11:00-12:00 EST Presenters: Andrew Grieve and Zhiwei Zang Chair: Jenny Devenport Location: Online via Zoom
Who is this event intended for? Anyone interested in hearing more about group sequential designs
What is the benefit of attending? To gain a better understanding about group sequential designs, the applications, the advantages and the disadvantages.
Registration
This event is free to attend for both Members of PSI and Non-Members.
To register, please click here.
Overview
Please join us to hear Andrew Grieve and Zhiwei Zhang present their recent work. The webinar will be chaired by Jenny Devenport.
Zhiwei Zhang, Carrie Nielson, Ching-Yi Chuo & Zhishen Ye: Information-based group sequential design for post-market safety monitoring of medical products using real world data - https://onlinelibrary.wiley.com/doi/10.1002/pst.2385
Post presentation discussions to information to follow.
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers will be made available to view prior to the meeting and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
The meetings are open to both PSI and non-PSI members.
Speaker details
Speaker
Biography
Jenny Devenport
A Ph.D. statistician by training, Jenny Devenport has more than 20 years of experience driving decisions in the healthcare industry including device /pharmaceutical development, quality monitoring and program evaluation in public health, and practice management in occupational healthcare systems. She aims to ask the right questions and develop optimal solutions to get patients the best care. She champions scientific curiosity, use of diverse data sources, effective measurement, and meticulous study design. As a leader and coach, she gets people to exceed themselves by leaving their comfort zones, appreciating their strengths, building strategic collaborations, forming extensive personal networks, and aiming for impact locally and globally.
Andy Grieve
Andrew P. Grieve is a Visiting Professor at King’s College London having recently retired from the position of Research Fellow in the Statistical Innovation group at UCB Pharma. He is a former Chair of PSI (Statisticians in the Pharmaceutical Industry) and a past-President of the Royal Statistical Society. He has over 45 years of experience as a biostatistician working in the pharmaceutical industry and academia. He has been active in the majority of areas of pharmaceutical R&D in which statistical methods and statisticians are intimately involved including drug discovery, pre-clinical toxicology, pharmaceutical development, pharmacokinetics and pharmacodynamics, phase I-IV of clinical development, manufacturing, health economics and clinical operations. Since the early 1980s he has promoted the use of Bayesian methods in pharmaceutical R&D and his statistical research has been primarily concerned with the implementation of Bayesian ideas and techniques. Latterly he has concentrated on the design and implementation of Bayesian adaptive trials, and the Probability of Success (PoS) of studies and drug development programs. He has published over 140 articles and is the author of two books. He has been an invited speaker at national and international conferences on over 300 occasions.
Zhiwei Zhang
Zhiwei Zhang is a senior director at Gilead Sciences. Before joining Gilead, he worked in academia and government agencies, including FDA and NIH. His research interests include causal inference and clinical trial design and analysis. Dr. Zhang has published over 100 research articles, mostly in statistical journals. He is an elected fellow of the American Statistical Association.
Date: Thursday 12th December 2024 Time: 16:00-17:00 GMT | 17:00-18:00 CET | 11:00-12:00 EST Presenters: Andrew Grieve and Zhiwei Zang Chair: Jenny Devenport Location: Online via Zoom
Who is this event intended for? Anyone interested in hearing more about group sequential designs
What is the benefit of attending? To gain a better understanding about group sequential designs, the applications, the advantages and the disadvantages.
Registration
This event is free to attend for both Members of PSI and Non-Members.
To register, please click here.
Overview
Please join us to hear Andrew Grieve and Zhiwei Zhang present their recent work. The webinar will be chaired by Jenny Devenport.
Zhiwei Zhang, Carrie Nielson, Ching-Yi Chuo & Zhishen Ye: Information-based group sequential design for post-market safety monitoring of medical products using real world data - https://onlinelibrary.wiley.com/doi/10.1002/pst.2385
Post presentation discussions to information to follow.
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers will be made available to view prior to the meeting and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
The meetings are open to both PSI and non-PSI members.
Speaker details
Speaker
Biography
Jenny Devenport
A Ph.D. statistician by training, Jenny Devenport has more than 20 years of experience driving decisions in the healthcare industry including device /pharmaceutical development, quality monitoring and program evaluation in public health, and practice management in occupational healthcare systems. She aims to ask the right questions and develop optimal solutions to get patients the best care. She champions scientific curiosity, use of diverse data sources, effective measurement, and meticulous study design. As a leader and coach, she gets people to exceed themselves by leaving their comfort zones, appreciating their strengths, building strategic collaborations, forming extensive personal networks, and aiming for impact locally and globally.
Andy Grieve
Andrew P. Grieve is a Visiting Professor at King’s College London having recently retired from the position of Research Fellow in the Statistical Innovation group at UCB Pharma. He is a former Chair of PSI (Statisticians in the Pharmaceutical Industry) and a past-President of the Royal Statistical Society. He has over 45 years of experience as a biostatistician working in the pharmaceutical industry and academia. He has been active in the majority of areas of pharmaceutical R&D in which statistical methods and statisticians are intimately involved including drug discovery, pre-clinical toxicology, pharmaceutical development, pharmacokinetics and pharmacodynamics, phase I-IV of clinical development, manufacturing, health economics and clinical operations. Since the early 1980s he has promoted the use of Bayesian methods in pharmaceutical R&D and his statistical research has been primarily concerned with the implementation of Bayesian ideas and techniques. Latterly he has concentrated on the design and implementation of Bayesian adaptive trials, and the Probability of Success (PoS) of studies and drug development programs. He has published over 140 articles and is the author of two books. He has been an invited speaker at national and international conferences on over 300 occasions.
Zhiwei Zhang
Zhiwei Zhang is a senior director at Gilead Sciences. Before joining Gilead, he worked in academia and government agencies, including FDA and NIH. His research interests include causal inference and clinical trial design and analysis. Dr. Zhang has published over 100 research articles, mostly in statistical journals. He is an elected fellow of the American Statistical Association.
Date: Thursday 12th December 2024 Time: 16:00-17:00 GMT | 17:00-18:00 CET | 11:00-12:00 EST Presenters: Andrew Grieve and Zhiwei Zang Chair: Jenny Devenport Location: Online via Zoom
Who is this event intended for? Anyone interested in hearing more about group sequential designs
What is the benefit of attending? To gain a better understanding about group sequential designs, the applications, the advantages and the disadvantages.
Registration
This event is free to attend for both Members of PSI and Non-Members.
To register, please click here.
Overview
Please join us to hear Andrew Grieve and Zhiwei Zhang present their recent work. The webinar will be chaired by Jenny Devenport.
Zhiwei Zhang, Carrie Nielson, Ching-Yi Chuo & Zhishen Ye: Information-based group sequential design for post-market safety monitoring of medical products using real world data - https://onlinelibrary.wiley.com/doi/10.1002/pst.2385
Post presentation discussions to information to follow.
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers will be made available to view prior to the meeting and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
The meetings are open to both PSI and non-PSI members.
Speaker details
Speaker
Biography
Jenny Devenport
A Ph.D. statistician by training, Jenny Devenport has more than 20 years of experience driving decisions in the healthcare industry including device /pharmaceutical development, quality monitoring and program evaluation in public health, and practice management in occupational healthcare systems. She aims to ask the right questions and develop optimal solutions to get patients the best care. She champions scientific curiosity, use of diverse data sources, effective measurement, and meticulous study design. As a leader and coach, she gets people to exceed themselves by leaving their comfort zones, appreciating their strengths, building strategic collaborations, forming extensive personal networks, and aiming for impact locally and globally.
Andy Grieve
Andrew P. Grieve is a Visiting Professor at King’s College London having recently retired from the position of Research Fellow in the Statistical Innovation group at UCB Pharma. He is a former Chair of PSI (Statisticians in the Pharmaceutical Industry) and a past-President of the Royal Statistical Society. He has over 45 years of experience as a biostatistician working in the pharmaceutical industry and academia. He has been active in the majority of areas of pharmaceutical R&D in which statistical methods and statisticians are intimately involved including drug discovery, pre-clinical toxicology, pharmaceutical development, pharmacokinetics and pharmacodynamics, phase I-IV of clinical development, manufacturing, health economics and clinical operations. Since the early 1980s he has promoted the use of Bayesian methods in pharmaceutical R&D and his statistical research has been primarily concerned with the implementation of Bayesian ideas and techniques. Latterly he has concentrated on the design and implementation of Bayesian adaptive trials, and the Probability of Success (PoS) of studies and drug development programs. He has published over 140 articles and is the author of two books. He has been an invited speaker at national and international conferences on over 300 occasions.
Zhiwei Zhang
Zhiwei Zhang is a senior director at Gilead Sciences. Before joining Gilead, he worked in academia and government agencies, including FDA and NIH. His research interests include causal inference and clinical trial design and analysis. Dr. Zhang has published over 100 research articles, mostly in statistical journals. He is an elected fellow of the American Statistical Association.
Date: Thursday 12th December 2024 Time: 16:00-17:00 GMT | 17:00-18:00 CET | 11:00-12:00 EST Presenters: Andrew Grieve and Zhiwei Zang Chair: Jenny Devenport Location: Online via Zoom
Who is this event intended for? Anyone interested in hearing more about group sequential designs
What is the benefit of attending? To gain a better understanding about group sequential designs, the applications, the advantages and the disadvantages.
Registration
This event is free to attend for both Members of PSI and Non-Members.
To register, please click here.
Overview
Please join us to hear Andrew Grieve and Zhiwei Zhang present their recent work. The webinar will be chaired by Jenny Devenport.
Zhiwei Zhang, Carrie Nielson, Ching-Yi Chuo & Zhishen Ye: Information-based group sequential design for post-market safety monitoring of medical products using real world data - https://onlinelibrary.wiley.com/doi/10.1002/pst.2385
Post presentation discussions to information to follow.
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers will be made available to view prior to the meeting and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
The meetings are open to both PSI and non-PSI members.
Speaker details
Speaker
Biography
Jenny Devenport
A Ph.D. statistician by training, Jenny Devenport has more than 20 years of experience driving decisions in the healthcare industry including device /pharmaceutical development, quality monitoring and program evaluation in public health, and practice management in occupational healthcare systems. She aims to ask the right questions and develop optimal solutions to get patients the best care. She champions scientific curiosity, use of diverse data sources, effective measurement, and meticulous study design. As a leader and coach, she gets people to exceed themselves by leaving their comfort zones, appreciating their strengths, building strategic collaborations, forming extensive personal networks, and aiming for impact locally and globally.
Andy Grieve
Andrew P. Grieve is a Visiting Professor at King’s College London having recently retired from the position of Research Fellow in the Statistical Innovation group at UCB Pharma. He is a former Chair of PSI (Statisticians in the Pharmaceutical Industry) and a past-President of the Royal Statistical Society. He has over 45 years of experience as a biostatistician working in the pharmaceutical industry and academia. He has been active in the majority of areas of pharmaceutical R&D in which statistical methods and statisticians are intimately involved including drug discovery, pre-clinical toxicology, pharmaceutical development, pharmacokinetics and pharmacodynamics, phase I-IV of clinical development, manufacturing, health economics and clinical operations. Since the early 1980s he has promoted the use of Bayesian methods in pharmaceutical R&D and his statistical research has been primarily concerned with the implementation of Bayesian ideas and techniques. Latterly he has concentrated on the design and implementation of Bayesian adaptive trials, and the Probability of Success (PoS) of studies and drug development programs. He has published over 140 articles and is the author of two books. He has been an invited speaker at national and international conferences on over 300 occasions.
Zhiwei Zhang
Zhiwei Zhang is a senior director at Gilead Sciences. Before joining Gilead, he worked in academia and government agencies, including FDA and NIH. His research interests include causal inference and clinical trial design and analysis. Dr. Zhang has published over 100 research articles, mostly in statistical journals. He is an elected fellow of the American Statistical Association.
Date: Thursday 12th December 2024 Time: 16:00-17:00 GMT | 17:00-18:00 CET | 11:00-12:00 EST Presenters: Andrew Grieve and Zhiwei Zang Chair: Jenny Devenport Location: Online via Zoom
Who is this event intended for? Anyone interested in hearing more about group sequential designs
What is the benefit of attending? To gain a better understanding about group sequential designs, the applications, the advantages and the disadvantages.
Registration
This event is free to attend for both Members of PSI and Non-Members.
To register, please click here.
Overview
Please join us to hear Andrew Grieve and Zhiwei Zhang present their recent work. The webinar will be chaired by Jenny Devenport.
Zhiwei Zhang, Carrie Nielson, Ching-Yi Chuo & Zhishen Ye: Information-based group sequential design for post-market safety monitoring of medical products using real world data - https://onlinelibrary.wiley.com/doi/10.1002/pst.2385
Post presentation discussions to information to follow.
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers will be made available to view prior to the meeting and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
The meetings are open to both PSI and non-PSI members.
Speaker details
Speaker
Biography
Jenny Devenport
A Ph.D. statistician by training, Jenny Devenport has more than 20 years of experience driving decisions in the healthcare industry including device /pharmaceutical development, quality monitoring and program evaluation in public health, and practice management in occupational healthcare systems. She aims to ask the right questions and develop optimal solutions to get patients the best care. She champions scientific curiosity, use of diverse data sources, effective measurement, and meticulous study design. As a leader and coach, she gets people to exceed themselves by leaving their comfort zones, appreciating their strengths, building strategic collaborations, forming extensive personal networks, and aiming for impact locally and globally.
Andy Grieve
Andrew P. Grieve is a Visiting Professor at King’s College London having recently retired from the position of Research Fellow in the Statistical Innovation group at UCB Pharma. He is a former Chair of PSI (Statisticians in the Pharmaceutical Industry) and a past-President of the Royal Statistical Society. He has over 45 years of experience as a biostatistician working in the pharmaceutical industry and academia. He has been active in the majority of areas of pharmaceutical R&D in which statistical methods and statisticians are intimately involved including drug discovery, pre-clinical toxicology, pharmaceutical development, pharmacokinetics and pharmacodynamics, phase I-IV of clinical development, manufacturing, health economics and clinical operations. Since the early 1980s he has promoted the use of Bayesian methods in pharmaceutical R&D and his statistical research has been primarily concerned with the implementation of Bayesian ideas and techniques. Latterly he has concentrated on the design and implementation of Bayesian adaptive trials, and the Probability of Success (PoS) of studies and drug development programs. He has published over 140 articles and is the author of two books. He has been an invited speaker at national and international conferences on over 300 occasions.
Zhiwei Zhang
Zhiwei Zhang is a senior director at Gilead Sciences. Before joining Gilead, he worked in academia and government agencies, including FDA and NIH. His research interests include causal inference and clinical trial design and analysis. Dr. Zhang has published over 100 research articles, mostly in statistical journals. He is an elected fellow of the American Statistical Association.
Date: Thursday 12th December 2024 Time: 16:00-17:00 GMT | 17:00-18:00 CET | 11:00-12:00 EST Presenters: Andrew Grieve and Zhiwei Zang Chair: Jenny Devenport Location: Online via Zoom
Who is this event intended for? Anyone interested in hearing more about group sequential designs
What is the benefit of attending? To gain a better understanding about group sequential designs, the applications, the advantages and the disadvantages.
Registration
This event is free to attend for both Members of PSI and Non-Members.
To register, please click here.
Overview
Please join us to hear Andrew Grieve and Zhiwei Zhang present their recent work. The webinar will be chaired by Jenny Devenport.
Zhiwei Zhang, Carrie Nielson, Ching-Yi Chuo & Zhishen Ye: Information-based group sequential design for post-market safety monitoring of medical products using real world data - https://onlinelibrary.wiley.com/doi/10.1002/pst.2385
Post presentation discussions to information to follow.
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers will be made available to view prior to the meeting and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
The meetings are open to both PSI and non-PSI members.
Speaker details
Speaker
Biography
Jenny Devenport
A Ph.D. statistician by training, Jenny Devenport has more than 20 years of experience driving decisions in the healthcare industry including device /pharmaceutical development, quality monitoring and program evaluation in public health, and practice management in occupational healthcare systems. She aims to ask the right questions and develop optimal solutions to get patients the best care. She champions scientific curiosity, use of diverse data sources, effective measurement, and meticulous study design. As a leader and coach, she gets people to exceed themselves by leaving their comfort zones, appreciating their strengths, building strategic collaborations, forming extensive personal networks, and aiming for impact locally and globally.
Andy Grieve
Andrew P. Grieve is a Visiting Professor at King’s College London having recently retired from the position of Research Fellow in the Statistical Innovation group at UCB Pharma. He is a former Chair of PSI (Statisticians in the Pharmaceutical Industry) and a past-President of the Royal Statistical Society. He has over 45 years of experience as a biostatistician working in the pharmaceutical industry and academia. He has been active in the majority of areas of pharmaceutical R&D in which statistical methods and statisticians are intimately involved including drug discovery, pre-clinical toxicology, pharmaceutical development, pharmacokinetics and pharmacodynamics, phase I-IV of clinical development, manufacturing, health economics and clinical operations. Since the early 1980s he has promoted the use of Bayesian methods in pharmaceutical R&D and his statistical research has been primarily concerned with the implementation of Bayesian ideas and techniques. Latterly he has concentrated on the design and implementation of Bayesian adaptive trials, and the Probability of Success (PoS) of studies and drug development programs. He has published over 140 articles and is the author of two books. He has been an invited speaker at national and international conferences on over 300 occasions.
Zhiwei Zhang
Zhiwei Zhang is a senior director at Gilead Sciences. Before joining Gilead, he worked in academia and government agencies, including FDA and NIH. His research interests include causal inference and clinical trial design and analysis. Dr. Zhang has published over 100 research articles, mostly in statistical journals. He is an elected fellow of the American Statistical Association.
Upcoming Events
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.
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.
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 Book Club: Another Door Opens – Book Club Special Event
This is a Book Club Special Event in response to the changes in our industry and as a supportive move to create community and connection for those navigating redundancy and uncertainty. Read the book in advance of the book club session then join the zoom call to discuss ideas. There will be breakout groups to connect with others, exchange experiences of how the book has helped, and offer support.
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.
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.
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 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.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
In this vital role you will generate evidence to meet Health Technology Assessment (HTA) requirements, while ensuring that the analyses performed meet required standards and are robust and valid.
Bristol Myers Squibb - Director, Statistical Methodology and Innovation
Lead the development of innovative statistical methods, provides expert consulting, oversees tools and software, and mentors team members while collaborating cross-functionally to address complex drug development challenges.
Phastar – Associate Director, Statistics – Real World Evidence (RWE)
As an Associate Director, Statistics (RWE) you will focus on supporting one of our key pharmaceutical clients within our FSP function. This will be a hands-on technical role, with oversight responsibilities and cross-functional exposure.
Phastar – Principal Statistician – Real World Evidence (RWE)
We are seeking an experienced Statistician to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at Principal level.
We are seeking an experienced Statistician to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at either Senior or Principal levels.
This position is deal for a statistician who values ownership, collaboration, and using data to enable confident development decisions and to support regulatory submissions.