Date: Thursday 12th September 2024 Time: 16:00-17:00 BST Presenters: Thomas Jemielita (Merck) and Björn Holzhauer (Novartis) Chair: To be confirmed Location: Online via Zoom
Who is this event intended for? Anyone interested in hearing more about subgroup and covariate analyses. What is the benefit of attending? To gain a better understanding about the limitations and challenges of MMRM from 2 recent authors in our Pharmaceutical Statistics journal.
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 Björn Holzhauer and Thomas Jemielita present their recent work.
Björn Holzhauer: Björn Holzhauer & Emmanuel Taiwo Adewuyi - “Super-covariates”: Using predicted control group outcome as a covariate in randomized clinical trials: https://onlinelibrary.wiley.com/doi/10.1002/pst.2329
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. Journal subscribers can access papers at any time.
Speaker details
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.
Scientific Meetings
PSI Journal Club Webinar: Subgroup and Covariate Analysis
Date: Thursday 12th September 2024 Time: 16:00-17:00 BST Presenters: Thomas Jemielita (Merck) and Björn Holzhauer (Novartis) Chair: To be confirmed Location: Online via Zoom
Who is this event intended for? Anyone interested in hearing more about subgroup and covariate analyses. What is the benefit of attending? To gain a better understanding about the limitations and challenges of MMRM from 2 recent authors in our Pharmaceutical Statistics journal.
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 Björn Holzhauer and Thomas Jemielita present their recent work.
Björn Holzhauer: Björn Holzhauer & Emmanuel Taiwo Adewuyi - “Super-covariates”: Using predicted control group outcome as a covariate in randomized clinical trials: https://onlinelibrary.wiley.com/doi/10.1002/pst.2329
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. Journal subscribers can access papers at any time.
Speaker details
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.
Training Courses
PSI Journal Club Webinar: Subgroup and Covariate Analysis
Date: Thursday 12th September 2024 Time: 16:00-17:00 BST Presenters: Thomas Jemielita (Merck) and Björn Holzhauer (Novartis) Chair: To be confirmed Location: Online via Zoom
Who is this event intended for? Anyone interested in hearing more about subgroup and covariate analyses. What is the benefit of attending? To gain a better understanding about the limitations and challenges of MMRM from 2 recent authors in our Pharmaceutical Statistics journal.
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 Björn Holzhauer and Thomas Jemielita present their recent work.
Björn Holzhauer: Björn Holzhauer & Emmanuel Taiwo Adewuyi - “Super-covariates”: Using predicted control group outcome as a covariate in randomized clinical trials: https://onlinelibrary.wiley.com/doi/10.1002/pst.2329
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. Journal subscribers can access papers at any time.
Speaker details
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.
Journal Club
PSI Journal Club Webinar: Subgroup and Covariate Analysis
Date: Thursday 12th September 2024 Time: 16:00-17:00 BST Presenters: Thomas Jemielita (Merck) and Björn Holzhauer (Novartis) Chair: To be confirmed Location: Online via Zoom
Who is this event intended for? Anyone interested in hearing more about subgroup and covariate analyses. What is the benefit of attending? To gain a better understanding about the limitations and challenges of MMRM from 2 recent authors in our Pharmaceutical Statistics journal.
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 Björn Holzhauer and Thomas Jemielita present their recent work.
Björn Holzhauer: Björn Holzhauer & Emmanuel Taiwo Adewuyi - “Super-covariates”: Using predicted control group outcome as a covariate in randomized clinical trials: https://onlinelibrary.wiley.com/doi/10.1002/pst.2329
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. Journal subscribers can access papers at any time.
Speaker details
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.
Webinars
PSI Journal Club Webinar: Subgroup and Covariate Analysis
Date: Thursday 12th September 2024 Time: 16:00-17:00 BST Presenters: Thomas Jemielita (Merck) and Björn Holzhauer (Novartis) Chair: To be confirmed Location: Online via Zoom
Who is this event intended for? Anyone interested in hearing more about subgroup and covariate analyses. What is the benefit of attending? To gain a better understanding about the limitations and challenges of MMRM from 2 recent authors in our Pharmaceutical Statistics journal.
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 Björn Holzhauer and Thomas Jemielita present their recent work.
Björn Holzhauer: Björn Holzhauer & Emmanuel Taiwo Adewuyi - “Super-covariates”: Using predicted control group outcome as a covariate in randomized clinical trials: https://onlinelibrary.wiley.com/doi/10.1002/pst.2329
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. Journal subscribers can access papers at any time.
Speaker details
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.
Careers Meetings
PSI Journal Club Webinar: Subgroup and Covariate Analysis
Date: Thursday 12th September 2024 Time: 16:00-17:00 BST Presenters: Thomas Jemielita (Merck) and Björn Holzhauer (Novartis) Chair: To be confirmed Location: Online via Zoom
Who is this event intended for? Anyone interested in hearing more about subgroup and covariate analyses. What is the benefit of attending? To gain a better understanding about the limitations and challenges of MMRM from 2 recent authors in our Pharmaceutical Statistics journal.
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 Björn Holzhauer and Thomas Jemielita present their recent work.
Björn Holzhauer: Björn Holzhauer & Emmanuel Taiwo Adewuyi - “Super-covariates”: Using predicted control group outcome as a covariate in randomized clinical trials: https://onlinelibrary.wiley.com/doi/10.1002/pst.2329
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. Journal subscribers can access papers at any time.
Speaker details
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.
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: Change: How organisations achieve hard-to-image results in uncertain and volatile times
Organizations have to adapt to the transforming landscape of our industry to ensure they continue to be successful in the future. Many of us are feeling the impact of organizational change. By reading John P Kotter’s book we can understand about organizational change and learn how to thrive, rather than just survive, through change.
Change, by John P Kotter (and his team), is a summary of all that he has learned over his decades of research and leading change. His book describes why many current approaches to change are inadequate and explains why new solutions need to give people a voice and a role in a new, change-embracing organization.
Develop your understanding of organisational change and become empowered to be part of your organisation’s change, by reading Change by John P Kotter and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply knowledge from the book in-between sessions.
PSI Book Club: Another Door Opens – Book Club Special Event
This is a Book Club Special Event in response to the changes in our industry and as a supportive move to create community and connection for those navigating redundancy and uncertainty. Read the book in advance of the book club session then join the zoom call to discuss ideas. There will be breakout groups to connect with others, exchange experiences of how the book has helped, and offer support.
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 networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Training Course: Propensity Scores: Practical Application in Non-randomised Studies
The course will introduce the topic of propensity scores and the use of external data. Covering the topics of matching and weighting as well as more advance topics of high dimension propensity scores, multi-valued treatments, double robustness and time-varying scenarios. There will be the opportunity to participate in some hands on practical exercises in R.
This two-afternoon virtual course provides a practical introduction to adaptive clinical trials, focusing on the concepts, applications, and regulatory principles outlined in ICH E20 through real-world examples and case studies.
PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics
Date: Wednesday 4th November 2026
A careers talk about medical statistics and how it plays a crucial role in developing new medicines. Learn about the field of medical statistics and how it plays a crucial role in developing groundbreaking new medicines, vaccines and healthcare products.
Date: 18 November 2026
This is an excellent opportunity for students to find out more about the field of medical statistics, talk to people from different organisations and make contacts for the future. All students currently studying for a mathematics or statistics-related BSc, MSc or PhD are invited to attend, and we welcome interest from exhibitors too.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Bristol Myers Squibb - Director, Statistical Methodology and Innovation
Lead the development of innovative statistical methods, provides expert consulting, oversees tools and software, and mentors team members while collaborating cross-functionally to address complex drug development challenges.
nQuery (Statistical Solutions) - Research Biostatistian
We're looking for a Biostatistician who thrives at the intersection of academic rigour and real-world software impact with a strong grounding in statistics and hands-on experience in biostatistics, clinical trials, or a closely related field
As a Senior Statistician, you will provide high-quality statistical support to one of our key-FSP clients. At Senior level you may also take on a supervisory role (e.g. line management and/or project management), depending on your experience and interest.
This position is deal for a statistician who values ownership, collaboration, and using data to enable confident development decisions and to support regulatory submissions.