Date: Thursday 9th November 2023 Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET Speakers: Kristian Brock and Peter Thall Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy. What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
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 Kristian Brock and Peter Thall present their recent work.
Presenters & Papers: 1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials' https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
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 are available to view prior to the meeting (see above) 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.
Speaker details
Speaker
Biography
Peter Thall
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes.
Kristian Brock
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing.
Chair
Sebastian Weber
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.
Scientific Meetings
PSI Journal Club: Bayesian Approaches in Efficacy and Safety
Date: Thursday 9th November 2023 Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET Speakers: Kristian Brock and Peter Thall Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy. What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
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 Kristian Brock and Peter Thall present their recent work.
Presenters & Papers: 1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials' https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
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 are available to view prior to the meeting (see above) 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.
Speaker details
Speaker
Biography
Peter Thall
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes.
Kristian Brock
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing.
Chair
Sebastian Weber
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.
Training Courses
PSI Journal Club: Bayesian Approaches in Efficacy and Safety
Date: Thursday 9th November 2023 Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET Speakers: Kristian Brock and Peter Thall Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy. What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
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 Kristian Brock and Peter Thall present their recent work.
Presenters & Papers: 1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials' https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
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 are available to view prior to the meeting (see above) 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.
Speaker details
Speaker
Biography
Peter Thall
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes.
Kristian Brock
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing.
Chair
Sebastian Weber
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.
Journal Club
PSI Journal Club: Bayesian Approaches in Efficacy and Safety
Date: Thursday 9th November 2023 Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET Speakers: Kristian Brock and Peter Thall Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy. What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
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 Kristian Brock and Peter Thall present their recent work.
Presenters & Papers: 1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials' https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
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 are available to view prior to the meeting (see above) 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.
Speaker details
Speaker
Biography
Peter Thall
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes.
Kristian Brock
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing.
Chair
Sebastian Weber
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.
Webinars
PSI Journal Club: Bayesian Approaches in Efficacy and Safety
Date: Thursday 9th November 2023 Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET Speakers: Kristian Brock and Peter Thall Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy. What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
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 Kristian Brock and Peter Thall present their recent work.
Presenters & Papers: 1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials' https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
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 are available to view prior to the meeting (see above) 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.
Speaker details
Speaker
Biography
Peter Thall
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes.
Kristian Brock
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing.
Chair
Sebastian Weber
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.
Careers Meetings
PSI Journal Club: Bayesian Approaches in Efficacy and Safety
Date: Thursday 9th November 2023 Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET Speakers: Kristian Brock and Peter Thall Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy. What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
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 Kristian Brock and Peter Thall present their recent work.
Presenters & Papers: 1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials' https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
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 are available to view prior to the meeting (see above) 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.
Speaker details
Speaker
Biography
Peter Thall
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes.
Kristian Brock
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing.
Chair
Sebastian Weber
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.
Upcoming Events
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 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.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Pre-Clinical SIG Webinar: AI agents for drug discovery and development
AI agents are large language models equipped with tools that can autonomously tackle challenging tasks. This talk will explore how generative AI agents can enable biomedical discovery.
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.
The Pre-Clinical Special Interest Group (SIG) Workshop 2025 will take place over two half-days on 7 - 8 October in Verona, Italy, bringing together experts from industry, academia, and regulatory institutions to discuss key challenges and innovations in pre-clinical research.
PSI Training Course: Introduction to Machine Learning
Four sessions will include ML foundation (including an introduction, data exploration for ML and dimensionality reduction and feature selection), Supervised learning (including support vector machines and model evaluation and interpretation), model optimization and unsupervised learning (including clustering) and advanced topics (including neural networks, deep learning and large language models).
The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.
Date: 19 November 2025
This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Associate Director Biostatistics in Early Development - Novartis
As an Associate Director Biostatistics Early Development, you will be a key member of our biostatistics group, you will play a crucial role in the design, analysis, and interpretation of clinical trials for early development programs.
Associate Director Biostatistics, Real World Data - Novartis
If you are passionate about biostatistics and real-world data, and are looking for an exciting opportunity to contribute to groundbreaking research, we encourage you to apply.
Are you passionate about making a difference in the world of healthcare? Novartis is seeking a dynamic and experienced professional to join our team in London at The Westworks.
Director of HTA Biostatistics & Medical Affairs - Novartis
As the Director of HTA Biostatistics & Medical Affairs, you will play a pivotal role in shaping the future of healthcare by providing strategic biostatistical leadership and expertise.
As a Senior Principal Biostatistician, you will be responsible and accountable for all statistical work, both scientific and operational, for one or more assigned clinical trials