Date: Tuesday 21st April 2026 Time: 14:00 - 15:30 (GMT) / 15:00 - 16:30 (CET) Location: Online via Zoom Speakers: Vivian Lanius (UCB), Francesca Callegari (Novartis) and Maarten van Dijk (Staburo GmbH)
Who is this event intended for?: Clinical researchers, medical writers, statisticians, and anyone engaged in reporting clinical trial results.
What is the benefit of attending?:
Key takeaways will be:
- Why estimands matter for decision-making and communication.
- Practical considerations for integrating estimands into study reports.
- Lessons learned from case studies and real-world applications.
Cost
This webinar is free to both Members of PSI and Non-Members.
Clear and transparent reporting of clinical trial results is essential for regulatory decision-making, scientific evaluation, and effective communication with healthcare professionals and patients. With the introduction of the ICH E9(R1) addendum on estimands and sensitivity analysis, the industry has a powerful framework to improve clarity around treatment effects. But how can this framework be effectively implemented in practice at the stage of reporting study results?
Join us for an insightful webinar where we explore practical strategies for applying the estimand framework in clinical study reporting. Drawing on real-world experiences and case studies, we will share recommendations to help you:
- Understand the role of estimands in improving transparency and interpretation of trial results.
- Navigate common challenges in implementing the framework during reporting.
- Apply best practices to enhance regulatory submissions, webposting in public registries (clinicaltrials.gov/CTIS), and scientific publications.
Whether you are involved in clinical trial design, data analysis, or regulatory submissions, this session will provide actionable guidance to realize the full potential of the estimand framework.
Speakers
Speaker
Biography
Vivian Lanius (UCB)
Vivian is a Statistical Methodology Lead in UCB’s Statistical Innovation group, a role she assumed in 2024 after more than 18 years as a statistician at Bayer. She serves as a EFSPI Council Member for the German member group APF and is Chair of the EFSPI Regulatory Statistics Workshop for 2025 and 2026. Vivian is also an active member of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), where she leads the reporting subteam.
Francesca Callegari (Novartis)
Francesca is as a Director of Biostatistics at Novartis. She began her career in 2003 as a biostatistician at Bristol Myers Squibb and has since accumulated over twenty years of experience at Novartis across multiple therapeutic areas. She is an active contributor to the Novartis Estimand Implementation Team as well as the EFSPI/EFPIA Estimand Implementation Working Group, with a particular focus on the reporting subteam.
Maarten van Dijk (Staburo GmbH)
Maarten is an associate director in the Data Transparency & Medical Writing group at Staburo GmbH, before moving to industry more than six years ago he worked as a researcher in academia. He is currently working to implement Estimands in clinical research both at Staburo GmbH and as part of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), reporting subteam.
Scientific Meetings
Enhancing Clinical Study Reporting with the Estimand Framework
Date: Tuesday 21st April 2026 Time: 14:00 - 15:30 (GMT) / 15:00 - 16:30 (CET) Location: Online via Zoom Speakers: Vivian Lanius (UCB), Francesca Callegari (Novartis) and Maarten van Dijk (Staburo GmbH)
Who is this event intended for?: Clinical researchers, medical writers, statisticians, and anyone engaged in reporting clinical trial results.
What is the benefit of attending?:
Key takeaways will be:
- Why estimands matter for decision-making and communication.
- Practical considerations for integrating estimands into study reports.
- Lessons learned from case studies and real-world applications.
Cost
This webinar is free to both Members of PSI and Non-Members.
Clear and transparent reporting of clinical trial results is essential for regulatory decision-making, scientific evaluation, and effective communication with healthcare professionals and patients. With the introduction of the ICH E9(R1) addendum on estimands and sensitivity analysis, the industry has a powerful framework to improve clarity around treatment effects. But how can this framework be effectively implemented in practice at the stage of reporting study results?
Join us for an insightful webinar where we explore practical strategies for applying the estimand framework in clinical study reporting. Drawing on real-world experiences and case studies, we will share recommendations to help you:
- Understand the role of estimands in improving transparency and interpretation of trial results.
- Navigate common challenges in implementing the framework during reporting.
- Apply best practices to enhance regulatory submissions, webposting in public registries (clinicaltrials.gov/CTIS), and scientific publications.
Whether you are involved in clinical trial design, data analysis, or regulatory submissions, this session will provide actionable guidance to realize the full potential of the estimand framework.
Speakers
Speaker
Biography
Vivian Lanius (UCB)
Vivian is a Statistical Methodology Lead in UCB’s Statistical Innovation group, a role she assumed in 2024 after more than 18 years as a statistician at Bayer. She serves as a EFSPI Council Member for the German member group APF and is Chair of the EFSPI Regulatory Statistics Workshop for 2025 and 2026. Vivian is also an active member of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), where she leads the reporting subteam.
Francesca Callegari (Novartis)
Francesca is as a Director of Biostatistics at Novartis. She began her career in 2003 as a biostatistician at Bristol Myers Squibb and has since accumulated over twenty years of experience at Novartis across multiple therapeutic areas. She is an active contributor to the Novartis Estimand Implementation Team as well as the EFSPI/EFPIA Estimand Implementation Working Group, with a particular focus on the reporting subteam.
Maarten van Dijk (Staburo GmbH)
Maarten is an associate director in the Data Transparency & Medical Writing group at Staburo GmbH, before moving to industry more than six years ago he worked as a researcher in academia. He is currently working to implement Estimands in clinical research both at Staburo GmbH and as part of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), reporting subteam.
Training Courses
Enhancing Clinical Study Reporting with the Estimand Framework
Date: Tuesday 21st April 2026 Time: 14:00 - 15:30 (GMT) / 15:00 - 16:30 (CET) Location: Online via Zoom Speakers: Vivian Lanius (UCB), Francesca Callegari (Novartis) and Maarten van Dijk (Staburo GmbH)
Who is this event intended for?: Clinical researchers, medical writers, statisticians, and anyone engaged in reporting clinical trial results.
What is the benefit of attending?:
Key takeaways will be:
- Why estimands matter for decision-making and communication.
- Practical considerations for integrating estimands into study reports.
- Lessons learned from case studies and real-world applications.
Cost
This webinar is free to both Members of PSI and Non-Members.
Clear and transparent reporting of clinical trial results is essential for regulatory decision-making, scientific evaluation, and effective communication with healthcare professionals and patients. With the introduction of the ICH E9(R1) addendum on estimands and sensitivity analysis, the industry has a powerful framework to improve clarity around treatment effects. But how can this framework be effectively implemented in practice at the stage of reporting study results?
Join us for an insightful webinar where we explore practical strategies for applying the estimand framework in clinical study reporting. Drawing on real-world experiences and case studies, we will share recommendations to help you:
- Understand the role of estimands in improving transparency and interpretation of trial results.
- Navigate common challenges in implementing the framework during reporting.
- Apply best practices to enhance regulatory submissions, webposting in public registries (clinicaltrials.gov/CTIS), and scientific publications.
Whether you are involved in clinical trial design, data analysis, or regulatory submissions, this session will provide actionable guidance to realize the full potential of the estimand framework.
Speakers
Speaker
Biography
Vivian Lanius (UCB)
Vivian is a Statistical Methodology Lead in UCB’s Statistical Innovation group, a role she assumed in 2024 after more than 18 years as a statistician at Bayer. She serves as a EFSPI Council Member for the German member group APF and is Chair of the EFSPI Regulatory Statistics Workshop for 2025 and 2026. Vivian is also an active member of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), where she leads the reporting subteam.
Francesca Callegari (Novartis)
Francesca is as a Director of Biostatistics at Novartis. She began her career in 2003 as a biostatistician at Bristol Myers Squibb and has since accumulated over twenty years of experience at Novartis across multiple therapeutic areas. She is an active contributor to the Novartis Estimand Implementation Team as well as the EFSPI/EFPIA Estimand Implementation Working Group, with a particular focus on the reporting subteam.
Maarten van Dijk (Staburo GmbH)
Maarten is an associate director in the Data Transparency & Medical Writing group at Staburo GmbH, before moving to industry more than six years ago he worked as a researcher in academia. He is currently working to implement Estimands in clinical research both at Staburo GmbH and as part of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), reporting subteam.
Journal Club
Enhancing Clinical Study Reporting with the Estimand Framework
Date: Tuesday 21st April 2026 Time: 14:00 - 15:30 (GMT) / 15:00 - 16:30 (CET) Location: Online via Zoom Speakers: Vivian Lanius (UCB), Francesca Callegari (Novartis) and Maarten van Dijk (Staburo GmbH)
Who is this event intended for?: Clinical researchers, medical writers, statisticians, and anyone engaged in reporting clinical trial results.
What is the benefit of attending?:
Key takeaways will be:
- Why estimands matter for decision-making and communication.
- Practical considerations for integrating estimands into study reports.
- Lessons learned from case studies and real-world applications.
Cost
This webinar is free to both Members of PSI and Non-Members.
Clear and transparent reporting of clinical trial results is essential for regulatory decision-making, scientific evaluation, and effective communication with healthcare professionals and patients. With the introduction of the ICH E9(R1) addendum on estimands and sensitivity analysis, the industry has a powerful framework to improve clarity around treatment effects. But how can this framework be effectively implemented in practice at the stage of reporting study results?
Join us for an insightful webinar where we explore practical strategies for applying the estimand framework in clinical study reporting. Drawing on real-world experiences and case studies, we will share recommendations to help you:
- Understand the role of estimands in improving transparency and interpretation of trial results.
- Navigate common challenges in implementing the framework during reporting.
- Apply best practices to enhance regulatory submissions, webposting in public registries (clinicaltrials.gov/CTIS), and scientific publications.
Whether you are involved in clinical trial design, data analysis, or regulatory submissions, this session will provide actionable guidance to realize the full potential of the estimand framework.
Speakers
Speaker
Biography
Vivian Lanius (UCB)
Vivian is a Statistical Methodology Lead in UCB’s Statistical Innovation group, a role she assumed in 2024 after more than 18 years as a statistician at Bayer. She serves as a EFSPI Council Member for the German member group APF and is Chair of the EFSPI Regulatory Statistics Workshop for 2025 and 2026. Vivian is also an active member of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), where she leads the reporting subteam.
Francesca Callegari (Novartis)
Francesca is as a Director of Biostatistics at Novartis. She began her career in 2003 as a biostatistician at Bristol Myers Squibb and has since accumulated over twenty years of experience at Novartis across multiple therapeutic areas. She is an active contributor to the Novartis Estimand Implementation Team as well as the EFSPI/EFPIA Estimand Implementation Working Group, with a particular focus on the reporting subteam.
Maarten van Dijk (Staburo GmbH)
Maarten is an associate director in the Data Transparency & Medical Writing group at Staburo GmbH, before moving to industry more than six years ago he worked as a researcher in academia. He is currently working to implement Estimands in clinical research both at Staburo GmbH and as part of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), reporting subteam.
Webinars
Enhancing Clinical Study Reporting with the Estimand Framework
Date: Tuesday 21st April 2026 Time: 14:00 - 15:30 (GMT) / 15:00 - 16:30 (CET) Location: Online via Zoom Speakers: Vivian Lanius (UCB), Francesca Callegari (Novartis) and Maarten van Dijk (Staburo GmbH)
Who is this event intended for?: Clinical researchers, medical writers, statisticians, and anyone engaged in reporting clinical trial results.
What is the benefit of attending?:
Key takeaways will be:
- Why estimands matter for decision-making and communication.
- Practical considerations for integrating estimands into study reports.
- Lessons learned from case studies and real-world applications.
Cost
This webinar is free to both Members of PSI and Non-Members.
Clear and transparent reporting of clinical trial results is essential for regulatory decision-making, scientific evaluation, and effective communication with healthcare professionals and patients. With the introduction of the ICH E9(R1) addendum on estimands and sensitivity analysis, the industry has a powerful framework to improve clarity around treatment effects. But how can this framework be effectively implemented in practice at the stage of reporting study results?
Join us for an insightful webinar where we explore practical strategies for applying the estimand framework in clinical study reporting. Drawing on real-world experiences and case studies, we will share recommendations to help you:
- Understand the role of estimands in improving transparency and interpretation of trial results.
- Navigate common challenges in implementing the framework during reporting.
- Apply best practices to enhance regulatory submissions, webposting in public registries (clinicaltrials.gov/CTIS), and scientific publications.
Whether you are involved in clinical trial design, data analysis, or regulatory submissions, this session will provide actionable guidance to realize the full potential of the estimand framework.
Speakers
Speaker
Biography
Vivian Lanius (UCB)
Vivian is a Statistical Methodology Lead in UCB’s Statistical Innovation group, a role she assumed in 2024 after more than 18 years as a statistician at Bayer. She serves as a EFSPI Council Member for the German member group APF and is Chair of the EFSPI Regulatory Statistics Workshop for 2025 and 2026. Vivian is also an active member of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), where she leads the reporting subteam.
Francesca Callegari (Novartis)
Francesca is as a Director of Biostatistics at Novartis. She began her career in 2003 as a biostatistician at Bristol Myers Squibb and has since accumulated over twenty years of experience at Novartis across multiple therapeutic areas. She is an active contributor to the Novartis Estimand Implementation Team as well as the EFSPI/EFPIA Estimand Implementation Working Group, with a particular focus on the reporting subteam.
Maarten van Dijk (Staburo GmbH)
Maarten is an associate director in the Data Transparency & Medical Writing group at Staburo GmbH, before moving to industry more than six years ago he worked as a researcher in academia. He is currently working to implement Estimands in clinical research both at Staburo GmbH and as part of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), reporting subteam.
Careers Meetings
Enhancing Clinical Study Reporting with the Estimand Framework
Date: Tuesday 21st April 2026 Time: 14:00 - 15:30 (GMT) / 15:00 - 16:30 (CET) Location: Online via Zoom Speakers: Vivian Lanius (UCB), Francesca Callegari (Novartis) and Maarten van Dijk (Staburo GmbH)
Who is this event intended for?: Clinical researchers, medical writers, statisticians, and anyone engaged in reporting clinical trial results.
What is the benefit of attending?:
Key takeaways will be:
- Why estimands matter for decision-making and communication.
- Practical considerations for integrating estimands into study reports.
- Lessons learned from case studies and real-world applications.
Cost
This webinar is free to both Members of PSI and Non-Members.
Clear and transparent reporting of clinical trial results is essential for regulatory decision-making, scientific evaluation, and effective communication with healthcare professionals and patients. With the introduction of the ICH E9(R1) addendum on estimands and sensitivity analysis, the industry has a powerful framework to improve clarity around treatment effects. But how can this framework be effectively implemented in practice at the stage of reporting study results?
Join us for an insightful webinar where we explore practical strategies for applying the estimand framework in clinical study reporting. Drawing on real-world experiences and case studies, we will share recommendations to help you:
- Understand the role of estimands in improving transparency and interpretation of trial results.
- Navigate common challenges in implementing the framework during reporting.
- Apply best practices to enhance regulatory submissions, webposting in public registries (clinicaltrials.gov/CTIS), and scientific publications.
Whether you are involved in clinical trial design, data analysis, or regulatory submissions, this session will provide actionable guidance to realize the full potential of the estimand framework.
Speakers
Speaker
Biography
Vivian Lanius (UCB)
Vivian is a Statistical Methodology Lead in UCB’s Statistical Innovation group, a role she assumed in 2024 after more than 18 years as a statistician at Bayer. She serves as a EFSPI Council Member for the German member group APF and is Chair of the EFSPI Regulatory Statistics Workshop for 2025 and 2026. Vivian is also an active member of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), where she leads the reporting subteam.
Francesca Callegari (Novartis)
Francesca is as a Director of Biostatistics at Novartis. She began her career in 2003 as a biostatistician at Bristol Myers Squibb and has since accumulated over twenty years of experience at Novartis across multiple therapeutic areas. She is an active contributor to the Novartis Estimand Implementation Team as well as the EFSPI/EFPIA Estimand Implementation Working Group, with a particular focus on the reporting subteam.
Maarten van Dijk (Staburo GmbH)
Maarten is an associate director in the Data Transparency & Medical Writing group at Staburo GmbH, before moving to industry more than six years ago he worked as a researcher in academia. He is currently working to implement Estimands in clinical research both at Staburo GmbH and as part of the EFSPI/EFPIA Estimand Implementation Working Group (EIWG), reporting subteam.
Upcoming Events
PSI Introduction to Industry Training (ITIT) Course - 2026/2027
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.
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, “Graphics Basics,” will introduce the fundamentals of producing graphics using the ggplot2 package.
Connecting the False Discovery Rate to Shrunk Estimates
A 1 hour online event, that includes a presentation followed by Q&A.
This talk will explore the “replication crisis” in science, focusing on how testing large numbers of hypotheses can lead to false positive findings. It introduces key statistical approaches—False Discovery Rate (FDR) and shrinkage methods—to address this issue, and explains their conceptual foundations and connections. The session will also highlight how these tools can be understood within an empirical-Bayesian framework, linking significance testing with effect size estimation.
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 Book Club: The AI Con – Joint with ASA Book Club
The Guardian described the authors of this book as refreshingly sarcastic! What is sold to us as AI, they announce, is just "a bill of goods": "A few major well-placed players are poised to accumulate significant wealth by extracting value from other people's creative work, personal data, or labour, and replacing quality services with artificial facsimiles."
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.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
A Lead Statistician builds and leads teams of statisticians and representatives from other functions and ensures the use of appropriate and efficient statistical analysis methods during development of Bayer products
As a Statistical Programmer II at ICON, you will play a vital role in the development, validation, and execution of statistical programs to support clinical trial analysis and reporting.
Leeds Clinical Trials Research Unit - Undergraduate Internships
The Internship is open to undergraduate students in the penultimate year of their undergraduate degree at a UK university, in a mathematical, statistical, or quantitative related field.
: We have an exciting opportunity for an Associate Director (AD), Statistical Programming, to join a passionate team within Advanced Quantitative Sciences- Development.
Novartis - Senior Principal Statistical Programmer
We have an exciting opportunity for a Senior Principal Statistical Programmer, to join a passionate team within Advanced Quantitative Sciences – Development.
Pierre Fabre - Clinical Development Safety Statistics Expert M/F
We are seeking a highly skilled and proactive Clinical Development Safety Statistics Expert to join our Biometry Department and the Biometry Leadership Team based in Toulouse (31, Oncopole) or Boulogne (92).
Pierre Fabre - Lead Statistician – Real World Evidence -CDI- M/F
Pierre Fabre Laboratories are hiring a highly skilled and experienced Lead Statistician – Real World Evidence (RWE) to join the Biometry Department, part of the Data Science & Biometry Department, based in Toulouse (Oncopôle) or Boulogne.
Pierre Fabre - Lead Statistician- Clinical Trials M/F
We are seeking a highly skilled and experienced Lead Statistician in Clinical Trials to join our Biometry Department based in Toulouse (31, Oncopole) or Boulogne (92).
Veramed - Manager/Senior Manager Statistics for Consultancy Team
An opportunity has arisen for a Statistician to join Veramed’s Statistical Consultancy Business Unit full time. The opportunity will be to provide statistical support to a variety of clients.
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.
As a Senior Statistician at Viatris, you will take a leading role in designing clinical studies, guiding statistical strategy, and ensuring that statistical deliverables meet the highest scientific and regulatory standards.