PSI Journal Club: Propensity Scores

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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 Training Course: Mixed Models and Repeated Measures

This course is presented through lectures and practical sessions using SAS code. It is suitable for statisticians working on clinical trials, who already have a good understanding of linear and generalised linear models.

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 Career Young Virtual Event (Q1 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.

PSI Estimand Online Training (4 Day Workshop)

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.

PSI Career Young Virtual Event (Q2 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.

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.

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
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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