PSI Journal Club Webinar: Subgroup and Covariate Analysis

PSI Mentoring 2025

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
Björn Holzhauer	Björn holds a doctorate in mathematics from the Otto-von-Guericke University Magdeburg. He has helped develop drugs in several disease areas at Novartis for 20 years. Björn is one on the authors of a collection of case studies on applied flexible Bayesian modelling in drug development with brms. He has worked on exploring the opportunities for machine learning in clinical development.
Thomas Jemielita	Thomas Jemielita is a Principal Scientist in Oncology Statistics, BARDS. Since joining Merck in 2017, his evolving job roles have spanned across various areas, including statistical support for early to late phase studies, biomarker studies, competitive intelligence, strategic initiatives, and real-world evidence studies. He has been actively involved in statistical research and has authored/co-authored over 20 scientific publications in peer-reviewed statistical and clinical journals, along with currently being a member of the ASA BIOP RWE Scientific Working Group for Rare Diseases. His currently research interests include causal inference, machine learning, and software development. Prior to joining Merck, Thomas received his PhD in biostatistics from the University of Pennsylvania in 2017.
Chris Harbron	Chris Harbron is an Expert Statistician leading capabilities in Advanced Analytics within the Data Sciences function at Roche. Through a variety of roles within the pharmaceutical industry Chris has worked in all stages of the drug development pipeline from drug discovery to early and late development. Chris has published and presented widely both within the statistical and the broader scientific literature.

Speaker	Biography
Björn Holzhauer	Björn holds a doctorate in mathematics from the Otto-von-Guericke University Magdeburg. He has helped develop drugs in several disease areas at Novartis for 20 years. Björn is one on the authors of a collection of case studies on applied flexible Bayesian modelling in drug development with brms. He has worked on exploring the opportunities for machine learning in clinical development.
Thomas Jemielita	Thomas Jemielita is a Principal Scientist in Oncology Statistics, BARDS. Since joining Merck in 2017, his evolving job roles have spanned across various areas, including statistical support for early to late phase studies, biomarker studies, competitive intelligence, strategic initiatives, and real-world evidence studies. He has been actively involved in statistical research and has authored/co-authored over 20 scientific publications in peer-reviewed statistical and clinical journals, along with currently being a member of the ASA BIOP RWE Scientific Working Group for Rare Diseases. His currently research interests include causal inference, machine learning, and software development. Prior to joining Merck, Thomas received his PhD in biostatistics from the University of Pennsylvania in 2017.
Chris Harbron	Chris Harbron is an Expert Statistician leading capabilities in Advanced Analytics within the Data Sciences function at Roche. Through a variety of roles within the pharmaceutical industry Chris has worked in all stages of the drug development pipeline from drug discovery to early and late development. Chris has published and presented widely both within the statistical and the broader scientific literature.

Speaker	Biography
Björn Holzhauer	Björn holds a doctorate in mathematics from the Otto-von-Guericke University Magdeburg. He has helped develop drugs in several disease areas at Novartis for 20 years. Björn is one on the authors of a collection of case studies on applied flexible Bayesian modelling in drug development with brms. He has worked on exploring the opportunities for machine learning in clinical development.
Thomas Jemielita	Thomas Jemielita is a Principal Scientist in Oncology Statistics, BARDS. Since joining Merck in 2017, his evolving job roles have spanned across various areas, including statistical support for early to late phase studies, biomarker studies, competitive intelligence, strategic initiatives, and real-world evidence studies. He has been actively involved in statistical research and has authored/co-authored over 20 scientific publications in peer-reviewed statistical and clinical journals, along with currently being a member of the ASA BIOP RWE Scientific Working Group for Rare Diseases. His currently research interests include causal inference, machine learning, and software development. Prior to joining Merck, Thomas received his PhD in biostatistics from the University of Pennsylvania in 2017.
Chris Harbron	Chris Harbron is an Expert Statistician leading capabilities in Advanced Analytics within the Data Sciences function at Roche. Through a variety of roles within the pharmaceutical industry Chris has worked in all stages of the drug development pipeline from drug discovery to early and late development. Chris has published and presented widely both within the statistical and the broader scientific literature.

Speaker	Biography
Björn Holzhauer	Björn holds a doctorate in mathematics from the Otto-von-Guericke University Magdeburg. He has helped develop drugs in several disease areas at Novartis for 20 years. Björn is one on the authors of a collection of case studies on applied flexible Bayesian modelling in drug development with brms. He has worked on exploring the opportunities for machine learning in clinical development.
Thomas Jemielita	Thomas Jemielita is a Principal Scientist in Oncology Statistics, BARDS. Since joining Merck in 2017, his evolving job roles have spanned across various areas, including statistical support for early to late phase studies, biomarker studies, competitive intelligence, strategic initiatives, and real-world evidence studies. He has been actively involved in statistical research and has authored/co-authored over 20 scientific publications in peer-reviewed statistical and clinical journals, along with currently being a member of the ASA BIOP RWE Scientific Working Group for Rare Diseases. His currently research interests include causal inference, machine learning, and software development. Prior to joining Merck, Thomas received his PhD in biostatistics from the University of Pennsylvania in 2017.
Chris Harbron	Chris Harbron is an Expert Statistician leading capabilities in Advanced Analytics within the Data Sciences function at Roche. Through a variety of roles within the pharmaceutical industry Chris has worked in all stages of the drug development pipeline from drug discovery to early and late development. Chris has published and presented widely both within the statistical and the broader scientific literature.

Speaker	Biography
Björn Holzhauer	Björn holds a doctorate in mathematics from the Otto-von-Guericke University Magdeburg. He has helped develop drugs in several disease areas at Novartis for 20 years. Björn is one on the authors of a collection of case studies on applied flexible Bayesian modelling in drug development with brms. He has worked on exploring the opportunities for machine learning in clinical development.
Thomas Jemielita	Thomas Jemielita is a Principal Scientist in Oncology Statistics, BARDS. Since joining Merck in 2017, his evolving job roles have spanned across various areas, including statistical support for early to late phase studies, biomarker studies, competitive intelligence, strategic initiatives, and real-world evidence studies. He has been actively involved in statistical research and has authored/co-authored over 20 scientific publications in peer-reviewed statistical and clinical journals, along with currently being a member of the ASA BIOP RWE Scientific Working Group for Rare Diseases. His currently research interests include causal inference, machine learning, and software development. Prior to joining Merck, Thomas received his PhD in biostatistics from the University of Pennsylvania in 2017.
Chris Harbron	Chris Harbron is an Expert Statistician leading capabilities in Advanced Analytics within the Data Sciences function at Roche. Through a variety of roles within the pharmaceutical industry Chris has worked in all stages of the drug development pipeline from drug discovery to early and late development. Chris has published and presented widely both within the statistical and the broader scientific literature.

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