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.
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Date: Ongoing 6 month cycle beginning late April/early May 2024
Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
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.
Overview of the day:
09:00 - Welcome, introduction, and networking
09:25 - Presentation from UCL and Strathclyde on programme delivery
09:45 - Presentation on evidence portfolios from Rachael
10:30 - Q&A Panel of current apprentices
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11:40 - Apprenticeship feedback and networking
12:10 - Close
Presentations and timings are subject to change.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
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.
Maths Meets Medicine: Exploring Careers in the Pharmaceutical Industry
This session will showcase how careers in pharmaceutical statistics can be both rewarding and impactful, with a focus on how mathematics is integral to the development of medicines. Students will hear from industry experts, explore diverse career paths, and learn why continuing to study math is key to unlocking exciting opportunities in the healthcare sector.
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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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
The BioMarin internship programme will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, whilst gaining an insight into the pharmaceutical/biotech industry.