Joint PSI, EFSPI & ASA BIOP Webinar: Complex Innovative Designs

PSI Introduction to Industry Training (ITIT) Course - 2025/2026

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

Urgent Meeting: Medical Statistician Apprenticeship Scheme

The UK government have recently announced that level 7 apprenticeships must be fully funded by the employer from January 2026, for any apprentice over the age of 21. With funding for MSc's at an all time low, and universities courses facing closures, the apprenticeship scheme remains as important as ever, as a tool to encourage new statisticians into our industry. In this dedicated meeting, Valerie Millar (chair of the apprenticeship scheme) will provide full updates on the government changes and seek feedback and ideas from employers, universities and apprentices on how to keep this scheme successfully running for many years to come.

PSI Webinar: Methodology and first results of the iRISE (improving Reproducibility In SciencE) consortium

This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.

One-day Event: Change Management for Moving to R/Open-Source

This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.

PSI Vaccines SIG Webinar: Challenges in Estimating Vaccine Effectiveness Against Progression to Severe Disease

This is a free webinar on Challenges in Estimating Vaccine Effectiveness Against Progression to Severe Disease.

PSI Book Club - The Art of Explanation: How to Communicate with Clarity and Confidence

Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.

PSI Training Course: Pediatric Extrapolation

This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.

PSI Career Young Virtual Event (Q3 2025)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

EFSPI/PSI Causal Inference SIG Webinar: Instrumental Variable Methods

The webinar is targeted at statisticians working in the pharmaceutical industry, and the objective is to 1) provide a basic understanding of IV methodology including how it relates to causal inference, and 2) present two inspirational pharma-relevant applications.

PSI Career Young Virtual Event (Q4 2025)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Speaker	Biography
John Scott (FDA)	John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design, co-chairs the CID Pilot Program, and was the lead author of the guidance document Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is past Editor of the journal, Pharmaceutical Statistics.
Olivier Collignon (GSK)	Dr Olivier Collignon works as Statistics Leader at GSK in the United Kingdom where he contributes to the development of clinical trials for immune-inflammatory diseases. He holds a PhD in Applied Mathematics and is especially interested in basket, umbrella and platform trials, use of historical controls and clinical prediction models. He previously worked as a biostatistician in France and Luxembourg for 16 years. During his mission at the Luxembourg Institute of Health he was seconded at the European Medicines Agency in London for 4 years, where he gained regulatory experience and participated to the scientific evaluation of the design and results of clinical trials to obtain marketing authorization of new drugs in Europe.
Dieter Häring (Novartis)	Dieter A. Häring, PhD, Sr. Director Biostatistics Novartis. Dieter is the Biostatistics Group Head for Neuroinflammation in Neuroscience Novartis. Dieter joined Novartis in 2008 and has been working in roles of increasing responsibility in Neuroscience Novartis on various Multiple Sclerosis programs, including the fingolimod (Gilenya), siponimod (Mayzent) and ofatumumab (Kesimpta) programs. He planned the re-design of the PARADIGMS study, which was the first successfully completed randomized controlled clinical trial in pediatric MS and led to the approval of Gilenya in pediatric MS. Currently Dieter is working on the NEOS trial, a study in children with multiple sclerosis, which uses a Bayesian design to borrow strength from historical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot program. Prior to joining Novartis, Dieter studied biology and statistics. Dieter holds an MSc in Biology from University of Basel, Switzerland; a PhD in Biology from ETH Zurich, Switzerland; an MSc in Statistics from the University of Neuchâtel, Switzerland. He worked for his post-Doc at the School of Mathematical Sciences at the University College Dublin, Ireland.
Marius Thomas (Novartis)	Marius Thomas, PhD is currently working as a Senior Principal Biostatistician in the Neuroscience development unit of Novartis. Since joining Novartis, he has worked on various projects in the area of multiple sclerosis. He is the trial statistician for NEOS, a study in children with multiple sclerosis, which uses a Bayesian design to borrow strength from historical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot program. Before joining Novartis, Marius was an early-stage researcher in the IDEAS (Improving Design, Evaluation and Analysis of early drug development Studies) European Union training network, where he worked on the development of new approaches for subgroup identification in clinical trials in close collaboration with the Novartis Statistical Methodology Group. Marius holds a PhD in Statistics from TU Dortmund University.

Speaker	Biography
John Scott (FDA)	John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design, co-chairs the CID Pilot Program, and was the lead author of the guidance document Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is past Editor of the journal, Pharmaceutical Statistics.
Olivier Collignon (GSK)	Dr Olivier Collignon works as Statistics Leader at GSK in the United Kingdom where he contributes to the development of clinical trials for immune-inflammatory diseases. He holds a PhD in Applied Mathematics and is especially interested in basket, umbrella and platform trials, use of historical controls and clinical prediction models. He previously worked as a biostatistician in France and Luxembourg for 16 years. During his mission at the Luxembourg Institute of Health he was seconded at the European Medicines Agency in London for 4 years, where he gained regulatory experience and participated to the scientific evaluation of the design and results of clinical trials to obtain marketing authorization of new drugs in Europe.
Dieter Häring (Novartis)	Dieter A. Häring, PhD, Sr. Director Biostatistics Novartis. Dieter is the Biostatistics Group Head for Neuroinflammation in Neuroscience Novartis. Dieter joined Novartis in 2008 and has been working in roles of increasing responsibility in Neuroscience Novartis on various Multiple Sclerosis programs, including the fingolimod (Gilenya), siponimod (Mayzent) and ofatumumab (Kesimpta) programs. He planned the re-design of the PARADIGMS study, which was the first successfully completed randomized controlled clinical trial in pediatric MS and led to the approval of Gilenya in pediatric MS. Currently Dieter is working on the NEOS trial, a study in children with multiple sclerosis, which uses a Bayesian design to borrow strength from historical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot program. Prior to joining Novartis, Dieter studied biology and statistics. Dieter holds an MSc in Biology from University of Basel, Switzerland; a PhD in Biology from ETH Zurich, Switzerland; an MSc in Statistics from the University of Neuchâtel, Switzerland. He worked for his post-Doc at the School of Mathematical Sciences at the University College Dublin, Ireland.
Marius Thomas (Novartis)	Marius Thomas, PhD is currently working as a Senior Principal Biostatistician in the Neuroscience development unit of Novartis. Since joining Novartis, he has worked on various projects in the area of multiple sclerosis. He is the trial statistician for NEOS, a study in children with multiple sclerosis, which uses a Bayesian design to borrow strength from historical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot program. Before joining Novartis, Marius was an early-stage researcher in the IDEAS (Improving Design, Evaluation and Analysis of early drug development Studies) European Union training network, where he worked on the development of new approaches for subgroup identification in clinical trials in close collaboration with the Novartis Statistical Methodology Group. Marius holds a PhD in Statistics from TU Dortmund University.

Speaker	Biography
John Scott (FDA)	John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design, co-chairs the CID Pilot Program, and was the lead author of the guidance document Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is past Editor of the journal, Pharmaceutical Statistics.
Olivier Collignon (GSK)	Dr Olivier Collignon works as Statistics Leader at GSK in the United Kingdom where he contributes to the development of clinical trials for immune-inflammatory diseases. He holds a PhD in Applied Mathematics and is especially interested in basket, umbrella and platform trials, use of historical controls and clinical prediction models. He previously worked as a biostatistician in France and Luxembourg for 16 years. During his mission at the Luxembourg Institute of Health he was seconded at the European Medicines Agency in London for 4 years, where he gained regulatory experience and participated to the scientific evaluation of the design and results of clinical trials to obtain marketing authorization of new drugs in Europe.
Dieter Häring (Novartis)	Dieter A. Häring, PhD, Sr. Director Biostatistics Novartis. Dieter is the Biostatistics Group Head for Neuroinflammation in Neuroscience Novartis. Dieter joined Novartis in 2008 and has been working in roles of increasing responsibility in Neuroscience Novartis on various Multiple Sclerosis programs, including the fingolimod (Gilenya), siponimod (Mayzent) and ofatumumab (Kesimpta) programs. He planned the re-design of the PARADIGMS study, which was the first successfully completed randomized controlled clinical trial in pediatric MS and led to the approval of Gilenya in pediatric MS. Currently Dieter is working on the NEOS trial, a study in children with multiple sclerosis, which uses a Bayesian design to borrow strength from historical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot program. Prior to joining Novartis, Dieter studied biology and statistics. Dieter holds an MSc in Biology from University of Basel, Switzerland; a PhD in Biology from ETH Zurich, Switzerland; an MSc in Statistics from the University of Neuchâtel, Switzerland. He worked for his post-Doc at the School of Mathematical Sciences at the University College Dublin, Ireland.
Marius Thomas (Novartis)	Marius Thomas, PhD is currently working as a Senior Principal Biostatistician in the Neuroscience development unit of Novartis. Since joining Novartis, he has worked on various projects in the area of multiple sclerosis. He is the trial statistician for NEOS, a study in children with multiple sclerosis, which uses a Bayesian design to borrow strength from historical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot program. Before joining Novartis, Marius was an early-stage researcher in the IDEAS (Improving Design, Evaluation and Analysis of early drug development Studies) European Union training network, where he worked on the development of new approaches for subgroup identification in clinical trials in close collaboration with the Novartis Statistical Methodology Group. Marius holds a PhD in Statistics from TU Dortmund University.

Speaker	Biography
John Scott (FDA)	John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design, co-chairs the CID Pilot Program, and was the lead author of the guidance document Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is past Editor of the journal, Pharmaceutical Statistics.
Olivier Collignon (GSK)	Dr Olivier Collignon works as Statistics Leader at GSK in the United Kingdom where he contributes to the development of clinical trials for immune-inflammatory diseases. He holds a PhD in Applied Mathematics and is especially interested in basket, umbrella and platform trials, use of historical controls and clinical prediction models. He previously worked as a biostatistician in France and Luxembourg for 16 years. During his mission at the Luxembourg Institute of Health he was seconded at the European Medicines Agency in London for 4 years, where he gained regulatory experience and participated to the scientific evaluation of the design and results of clinical trials to obtain marketing authorization of new drugs in Europe.
Dieter Häring (Novartis)	Dieter A. Häring, PhD, Sr. Director Biostatistics Novartis. Dieter is the Biostatistics Group Head for Neuroinflammation in Neuroscience Novartis. Dieter joined Novartis in 2008 and has been working in roles of increasing responsibility in Neuroscience Novartis on various Multiple Sclerosis programs, including the fingolimod (Gilenya), siponimod (Mayzent) and ofatumumab (Kesimpta) programs. He planned the re-design of the PARADIGMS study, which was the first successfully completed randomized controlled clinical trial in pediatric MS and led to the approval of Gilenya in pediatric MS. Currently Dieter is working on the NEOS trial, a study in children with multiple sclerosis, which uses a Bayesian design to borrow strength from historical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot program. Prior to joining Novartis, Dieter studied biology and statistics. Dieter holds an MSc in Biology from University of Basel, Switzerland; a PhD in Biology from ETH Zurich, Switzerland; an MSc in Statistics from the University of Neuchâtel, Switzerland. He worked for his post-Doc at the School of Mathematical Sciences at the University College Dublin, Ireland.
Marius Thomas (Novartis)	Marius Thomas, PhD is currently working as a Senior Principal Biostatistician in the Neuroscience development unit of Novartis. Since joining Novartis, he has worked on various projects in the area of multiple sclerosis. He is the trial statistician for NEOS, a study in children with multiple sclerosis, which uses a Bayesian design to borrow strength from historical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot program. Before joining Novartis, Marius was an early-stage researcher in the IDEAS (Improving Design, Evaluation and Analysis of early drug development Studies) European Union training network, where he worked on the development of new approaches for subgroup identification in clinical trials in close collaboration with the Novartis Statistical Methodology Group. Marius holds a PhD in Statistics from TU Dortmund University.

Speaker	Biography
John Scott (FDA)	John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA VI efforts in Complex and Innovative Trial Design, co-chairs the CID Pilot Program, and was the lead author of the guidance document Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is past Editor of the journal, Pharmaceutical Statistics.
Olivier Collignon (GSK)	Dr Olivier Collignon works as Statistics Leader at GSK in the United Kingdom where he contributes to the development of clinical trials for immune-inflammatory diseases. He holds a PhD in Applied Mathematics and is especially interested in basket, umbrella and platform trials, use of historical controls and clinical prediction models. He previously worked as a biostatistician in France and Luxembourg for 16 years. During his mission at the Luxembourg Institute of Health he was seconded at the European Medicines Agency in London for 4 years, where he gained regulatory experience and participated to the scientific evaluation of the design and results of clinical trials to obtain marketing authorization of new drugs in Europe.
Dieter Häring (Novartis)	Dieter A. Häring, PhD, Sr. Director Biostatistics Novartis. Dieter is the Biostatistics Group Head for Neuroinflammation in Neuroscience Novartis. Dieter joined Novartis in 2008 and has been working in roles of increasing responsibility in Neuroscience Novartis on various Multiple Sclerosis programs, including the fingolimod (Gilenya), siponimod (Mayzent) and ofatumumab (Kesimpta) programs. He planned the re-design of the PARADIGMS study, which was the first successfully completed randomized controlled clinical trial in pediatric MS and led to the approval of Gilenya in pediatric MS. Currently Dieter is working on the NEOS trial, a study in children with multiple sclerosis, which uses a Bayesian design to borrow strength from historical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot program. Prior to joining Novartis, Dieter studied biology and statistics. Dieter holds an MSc in Biology from University of Basel, Switzerland; a PhD in Biology from ETH Zurich, Switzerland; an MSc in Statistics from the University of Neuchâtel, Switzerland. He worked for his post-Doc at the School of Mathematical Sciences at the University College Dublin, Ireland.
Marius Thomas (Novartis)	Marius Thomas, PhD is currently working as a Senior Principal Biostatistician in the Neuroscience development unit of Novartis. Since joining Novartis, he has worked on various projects in the area of multiple sclerosis. He is the trial statistician for NEOS, a study in children with multiple sclerosis, which uses a Bayesian design to borrow strength from historical trials in adults and children. The design was extensively discussed with the FDA as part of their CID pilot program. Before joining Novartis, Marius was an early-stage researcher in the IDEAS (Improving Design, Evaluation and Analysis of early drug development Studies) European Union training network, where he worked on the development of new approaches for subgroup identification in clinical trials in close collaboration with the Novartis Statistical Methodology Group. Marius holds a PhD in Statistics from TU Dortmund University.

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