PSI Journal Club: Propensity Scores

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.

AIMS SIG - Open-Source Lunch Bites

Topic: R Package Basics. 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 month’s session, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.

PSI Mentoring 2026

Date: Ongoing 6 month cycle beginning late April/early May 2026 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 Book Club Lunch and Learn: Communicating with Clarity and Confidence

If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event! Haven’t read the book yet? Pick up a copy today and join us. Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.

PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities

This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation. The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication. The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication. The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.

Speaker	Biography
Dr. Heng Li	Dr. Heng Li is a Lead Mathematical Statistician in the Division of Biostatistics, CDRH/FDA. He is instrumental in the establishment and evaluation of policies and procedures to maintain a unified and consistent program for biostatistical aspects of the regulation of medical device. He leads a team of statisticians in technical reviews and research. He has made substantial contributions in advancing regulatory statistics, especially propensity score-based methods, including developing and implementing novel propensity score-based approaches for leveraging real-world evidence to support regulatory decision-making.
Dr. Lilly Yue	Dr. Lilly Yue is a Deputy Director, Division of Biostatistics in the FDA's Center for Devices and Radiological Health, where she oversees statistical reviews of therapeutic and diagnostic medical devices. She has played a key leadership role in advancing regulatory statistics, including efforts on adapting and advancing propensity score methodology for premarket observational studies and on developing and implementing the novel propensity score-integrated approaches for leveraging real-world evidence to support regulatory decision-making. Dr. Yue is an Editor-in-Chief of Pharmaceutical Statistics and served as an Associate Editor (and a Guest Editor) for Journal of Biopharmaceutical Statistics and Pharmaceutical Statistics. She is a Fellow of the American Statistical Association.
Dr. Jason (Jixian) Wang	Jason (Jixian) Wang is a statistician in Statistical Methodology Group in Bristol Myers Squibb based in Switzerland. He has more than 20 years’ experience in the pharmaceutical industry, has worked in several therapeutic areas such as cardiovascular, oncology, hematology, and cell therapies, and in difference phases including clinical development, in which he did multiple regulatory submissions, as well as pre-clinical statistics, clinical pharmacology, and post-marketing drug safety and HTA. He was an academic researcher in biostatistics and epidemiology before joining the industry. He has a wide range of research interests including casual inference, innovative trial designs, dose optimization, machine learning, and PK/PD and health economics modeling and simulation. He published more than 60 papers, one book and two book chapters. He is a member of the RWD SIG in PSI/EFSPI.

Chair	Biography
Amy Mulick	Amy is Head of the Evidence and Value Generation group at Veramed, which generates clinical evidence for pharmaceutical products and medical devices using data collected partially or wholly outside the context of randomised controlled trials. Previously she was based at the London School of Hygiene and Tropical Medicine using the Clinical Practice Research Datalink (CPRD) to research disease epidemiology, and developing a novel cause of death estimation method to cope with sparse data inputs. She has expertise in Bayesian methods for evidence synthesis as well as causal and predictive statistical modelling.

Speaker	Biography
Dr. Heng Li	Dr. Heng Li is a Lead Mathematical Statistician in the Division of Biostatistics, CDRH/FDA. He is instrumental in the establishment and evaluation of policies and procedures to maintain a unified and consistent program for biostatistical aspects of the regulation of medical device. He leads a team of statisticians in technical reviews and research. He has made substantial contributions in advancing regulatory statistics, especially propensity score-based methods, including developing and implementing novel propensity score-based approaches for leveraging real-world evidence to support regulatory decision-making.
Dr. Lilly Yue	Dr. Lilly Yue is a Deputy Director, Division of Biostatistics in the FDA's Center for Devices and Radiological Health, where she oversees statistical reviews of therapeutic and diagnostic medical devices. She has played a key leadership role in advancing regulatory statistics, including efforts on adapting and advancing propensity score methodology for premarket observational studies and on developing and implementing the novel propensity score-integrated approaches for leveraging real-world evidence to support regulatory decision-making. Dr. Yue is an Editor-in-Chief of Pharmaceutical Statistics and served as an Associate Editor (and a Guest Editor) for Journal of Biopharmaceutical Statistics and Pharmaceutical Statistics. She is a Fellow of the American Statistical Association.
Dr. Jason (Jixian) Wang	Jason (Jixian) Wang is a statistician in Statistical Methodology Group in Bristol Myers Squibb based in Switzerland. He has more than 20 years’ experience in the pharmaceutical industry, has worked in several therapeutic areas such as cardiovascular, oncology, hematology, and cell therapies, and in difference phases including clinical development, in which he did multiple regulatory submissions, as well as pre-clinical statistics, clinical pharmacology, and post-marketing drug safety and HTA. He was an academic researcher in biostatistics and epidemiology before joining the industry. He has a wide range of research interests including casual inference, innovative trial designs, dose optimization, machine learning, and PK/PD and health economics modeling and simulation. He published more than 60 papers, one book and two book chapters. He is a member of the RWD SIG in PSI/EFSPI.

Chair	Biography
Amy Mulick	Amy is Head of the Evidence and Value Generation group at Veramed, which generates clinical evidence for pharmaceutical products and medical devices using data collected partially or wholly outside the context of randomised controlled trials. Previously she was based at the London School of Hygiene and Tropical Medicine using the Clinical Practice Research Datalink (CPRD) to research disease epidemiology, and developing a novel cause of death estimation method to cope with sparse data inputs. She has expertise in Bayesian methods for evidence synthesis as well as causal and predictive statistical modelling.

Speaker	Biography
Dr. Heng Li	Dr. Heng Li is a Lead Mathematical Statistician in the Division of Biostatistics, CDRH/FDA. He is instrumental in the establishment and evaluation of policies and procedures to maintain a unified and consistent program for biostatistical aspects of the regulation of medical device. He leads a team of statisticians in technical reviews and research. He has made substantial contributions in advancing regulatory statistics, especially propensity score-based methods, including developing and implementing novel propensity score-based approaches for leveraging real-world evidence to support regulatory decision-making.
Dr. Lilly Yue	Dr. Lilly Yue is a Deputy Director, Division of Biostatistics in the FDA's Center for Devices and Radiological Health, where she oversees statistical reviews of therapeutic and diagnostic medical devices. She has played a key leadership role in advancing regulatory statistics, including efforts on adapting and advancing propensity score methodology for premarket observational studies and on developing and implementing the novel propensity score-integrated approaches for leveraging real-world evidence to support regulatory decision-making. Dr. Yue is an Editor-in-Chief of Pharmaceutical Statistics and served as an Associate Editor (and a Guest Editor) for Journal of Biopharmaceutical Statistics and Pharmaceutical Statistics. She is a Fellow of the American Statistical Association.
Dr. Jason (Jixian) Wang	Jason (Jixian) Wang is a statistician in Statistical Methodology Group in Bristol Myers Squibb based in Switzerland. He has more than 20 years’ experience in the pharmaceutical industry, has worked in several therapeutic areas such as cardiovascular, oncology, hematology, and cell therapies, and in difference phases including clinical development, in which he did multiple regulatory submissions, as well as pre-clinical statistics, clinical pharmacology, and post-marketing drug safety and HTA. He was an academic researcher in biostatistics and epidemiology before joining the industry. He has a wide range of research interests including casual inference, innovative trial designs, dose optimization, machine learning, and PK/PD and health economics modeling and simulation. He published more than 60 papers, one book and two book chapters. He is a member of the RWD SIG in PSI/EFSPI.

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