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 Book Club: Change: How organisations achieve hard-to-imagine 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.
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 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.
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.
Making Estimands Work - Practical Approaches with Implementation in Data Standards
This event will discuss the impact of the estimand framework on data flow and data handling for analysis datasets (ADaM). What are the considerations to produce data sets suitable for estimation of estimands and traceability of the occurrence of intercurrent events. This webinar will include tips for best practice, based on the White paper Implementation of ICH E9(R1) Estimands Framework using Data Standards.
PSI/EFSPI Biomarker SIG Webinar: Statistical Methods for ctDNA Data
This webinar will describe what ctDNA is and what the key challenges are for analysing it. We will then summarise and review methods that were published over the last few years for analysing ctDNA data.
The morning will be dedicated to networking opportunities, helping attendees build connections with peers and professionals. In the afternoon, participants can attend a series of talks and workshops, including a career panel featuring speakers from both academia and industry, offering insights into various career paths. There will also be a statistical workshop, as well as the opportunity to learn about and debate some of the hot topics in the world of medical statistics. To wrap up the day, we’re exploring interest in an informal after-work networking event for those keen to continue the conversation.
Joint PSI/EFSPI, Phuse, ASA Safety Working Group Webinar Series: Overview of safety analysis and implementation process of safety surveillance in ongoing studies
The session will have three speakers and a discussant. This session will be the first in a series of webinars around safety in clinical trials. The series is co-organized by PSI, ASA-Biopharm safety working group and PHUSE.
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 Vaccines SIG Webinar: Statistical Immune Correlate Analysis of Hemagglutination Inhibition Titers for an mRNA-based Influenza Vaccine
This 1-hour webinar is designed for statisticians with an interest in vaccine development, to learn about the recent application of statistical immune correlate analysis in vaccine development. Specifically, an application of such analyses to evaluate hemagglutination inhibition titers for an influenza vaccine
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.
Aligning Estimation with the Clinical Question of Interest
This webinar will focus on aligning estimation to estimands. How do different strategies for handling intercurrent events and missing data handling influence the choice of estimation method, with illustration using a case study.
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 Careers Coaching Series: Peer Support Initiative
This 10-month peer support programme is aimed at professionals with five or more years of experience who are seeking structured development and connection with peers at a similar career stage. Through 5 bi-monthly topics, participants will engage in coach-led presentations, small-group discussions, and regular progress reviews focused on achieving tangible outcomes.
In this vital role you will generate evidence to meet Health Technology Assessment (HTA) requirements, while ensuring that the analyses performed meet required standards and are robust and valid.
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.
Phastar – Associate Director, Statistics – Real World Evidence (RWE)
As an Associate Director, Statistics (RWE) you will focus on supporting one of our key pharmaceutical clients within our FSP function. This will be a hands-on technical role, with oversight responsibilities and cross-functional exposure.
Phastar – Principal Statistician – Real World Evidence (RWE)
We are seeking an experienced Statistician to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at Principal level.
We are seeking an experienced Statistician to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at either Senior or Principal levels.
This position is deal for a statistician who values ownership, collaboration, and using data to enable confident development decisions and to support regulatory submissions.
