Date: Thursday 30th March 2023 Time:14:00-15:30 BST | 15:00-16:30 CEST | 09:00-10:30 EST Speakers: Judith Anzures-Cabrera (Roche), Nikhil Kamath (Roche), Sue McKendrick (PPD), Antonia Morga (Astellas), and David Wright (AstraZeneca).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians and health technology assessors. What is the benefit of attending? Attendees will have the opportunity to hear the perspectives of a variety of stakeholders in determining estimands, in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.
Registration
Registration for this webinar is free to both Members of PSI and Non-Members.
Please click here to register.
Overview
This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for different stakeholder questions of interest including how to develop transparent estimands for product labels.
The target outcomes are as follows:
• To apply the estimand framework to a challenging realistic setting
• To appreciate the different stakeholder views when determining estimands
• To understand the relative merits of different strategies for intercurrent events
• Understanding implementation challenges and possible solutions
To view the flyer for this event, please click here.
Speaker Details
Speaker
Biography
Judith Anzures-Cabrera
Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Working Group where she leads the Training sub-team.
Nikhil Kamath
Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology, Infectious Disease, and Ophthalmology at Roche.
Antonia Morga
Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.
David Wright
David Wright is Head of Statistical Innovation at AstraZeneca, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.
Sue McKendrick
Sue McKendrick is a Statistical Science Director leading the cross-functional Estimand Working Group at PPD and is also a member of the EIWG training subteam.
Scientific Meetings
PSI EIWG Webinar: Proposing Estimands from Different Perspectives
Date: Thursday 30th March 2023 Time:14:00-15:30 BST | 15:00-16:30 CEST | 09:00-10:30 EST Speakers: Judith Anzures-Cabrera (Roche), Nikhil Kamath (Roche), Sue McKendrick (PPD), Antonia Morga (Astellas), and David Wright (AstraZeneca).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians and health technology assessors. What is the benefit of attending? Attendees will have the opportunity to hear the perspectives of a variety of stakeholders in determining estimands, in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.
Registration
Registration for this webinar is free to both Members of PSI and Non-Members.
Please click here to register.
Overview
This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for different stakeholder questions of interest including how to develop transparent estimands for product labels.
The target outcomes are as follows:
• To apply the estimand framework to a challenging realistic setting
• To appreciate the different stakeholder views when determining estimands
• To understand the relative merits of different strategies for intercurrent events
• Understanding implementation challenges and possible solutions
To view the flyer for this event, please click here.
Speaker Details
Speaker
Biography
Judith Anzures-Cabrera
Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Working Group where she leads the Training sub-team.
Nikhil Kamath
Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology, Infectious Disease, and Ophthalmology at Roche.
Antonia Morga
Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.
David Wright
David Wright is Head of Statistical Innovation at AstraZeneca, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.
Sue McKendrick
Sue McKendrick is a Statistical Science Director leading the cross-functional Estimand Working Group at PPD and is also a member of the EIWG training subteam.
Training Courses
PSI EIWG Webinar: Proposing Estimands from Different Perspectives
Date: Thursday 30th March 2023 Time:14:00-15:30 BST | 15:00-16:30 CEST | 09:00-10:30 EST Speakers: Judith Anzures-Cabrera (Roche), Nikhil Kamath (Roche), Sue McKendrick (PPD), Antonia Morga (Astellas), and David Wright (AstraZeneca).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians and health technology assessors. What is the benefit of attending? Attendees will have the opportunity to hear the perspectives of a variety of stakeholders in determining estimands, in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.
Registration
Registration for this webinar is free to both Members of PSI and Non-Members.
Please click here to register.
Overview
This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for different stakeholder questions of interest including how to develop transparent estimands for product labels.
The target outcomes are as follows:
• To apply the estimand framework to a challenging realistic setting
• To appreciate the different stakeholder views when determining estimands
• To understand the relative merits of different strategies for intercurrent events
• Understanding implementation challenges and possible solutions
To view the flyer for this event, please click here.
Speaker Details
Speaker
Biography
Judith Anzures-Cabrera
Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Working Group where she leads the Training sub-team.
Nikhil Kamath
Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology, Infectious Disease, and Ophthalmology at Roche.
Antonia Morga
Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.
David Wright
David Wright is Head of Statistical Innovation at AstraZeneca, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.
Sue McKendrick
Sue McKendrick is a Statistical Science Director leading the cross-functional Estimand Working Group at PPD and is also a member of the EIWG training subteam.
Journal Club
PSI EIWG Webinar: Proposing Estimands from Different Perspectives
Date: Thursday 30th March 2023 Time:14:00-15:30 BST | 15:00-16:30 CEST | 09:00-10:30 EST Speakers: Judith Anzures-Cabrera (Roche), Nikhil Kamath (Roche), Sue McKendrick (PPD), Antonia Morga (Astellas), and David Wright (AstraZeneca).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians and health technology assessors. What is the benefit of attending? Attendees will have the opportunity to hear the perspectives of a variety of stakeholders in determining estimands, in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.
Registration
Registration for this webinar is free to both Members of PSI and Non-Members.
Please click here to register.
Overview
This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for different stakeholder questions of interest including how to develop transparent estimands for product labels.
The target outcomes are as follows:
• To apply the estimand framework to a challenging realistic setting
• To appreciate the different stakeholder views when determining estimands
• To understand the relative merits of different strategies for intercurrent events
• Understanding implementation challenges and possible solutions
To view the flyer for this event, please click here.
Speaker Details
Speaker
Biography
Judith Anzures-Cabrera
Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Working Group where she leads the Training sub-team.
Nikhil Kamath
Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology, Infectious Disease, and Ophthalmology at Roche.
Antonia Morga
Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.
David Wright
David Wright is Head of Statistical Innovation at AstraZeneca, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.
Sue McKendrick
Sue McKendrick is a Statistical Science Director leading the cross-functional Estimand Working Group at PPD and is also a member of the EIWG training subteam.
Webinars
PSI EIWG Webinar: Proposing Estimands from Different Perspectives
Date: Thursday 30th March 2023 Time:14:00-15:30 BST | 15:00-16:30 CEST | 09:00-10:30 EST Speakers: Judith Anzures-Cabrera (Roche), Nikhil Kamath (Roche), Sue McKendrick (PPD), Antonia Morga (Astellas), and David Wright (AstraZeneca).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians and health technology assessors. What is the benefit of attending? Attendees will have the opportunity to hear the perspectives of a variety of stakeholders in determining estimands, in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.
Registration
Registration for this webinar is free to both Members of PSI and Non-Members.
Please click here to register.
Overview
This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for different stakeholder questions of interest including how to develop transparent estimands for product labels.
The target outcomes are as follows:
• To apply the estimand framework to a challenging realistic setting
• To appreciate the different stakeholder views when determining estimands
• To understand the relative merits of different strategies for intercurrent events
• Understanding implementation challenges and possible solutions
To view the flyer for this event, please click here.
Speaker Details
Speaker
Biography
Judith Anzures-Cabrera
Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Working Group where she leads the Training sub-team.
Nikhil Kamath
Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology, Infectious Disease, and Ophthalmology at Roche.
Antonia Morga
Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.
David Wright
David Wright is Head of Statistical Innovation at AstraZeneca, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.
Sue McKendrick
Sue McKendrick is a Statistical Science Director leading the cross-functional Estimand Working Group at PPD and is also a member of the EIWG training subteam.
Careers Meetings
PSI EIWG Webinar: Proposing Estimands from Different Perspectives
Date: Thursday 30th March 2023 Time:14:00-15:30 BST | 15:00-16:30 CEST | 09:00-10:30 EST Speakers: Judith Anzures-Cabrera (Roche), Nikhil Kamath (Roche), Sue McKendrick (PPD), Antonia Morga (Astellas), and David Wright (AstraZeneca).
Who is this event intended for? Clinicians, Regulators, Investigators, Academics, members of Ethics Committees, Statisticians and health technology assessors. What is the benefit of attending? Attendees will have the opportunity to hear the perspectives of a variety of stakeholders in determining estimands, in turn understanding more about challenges and possible solutions when applying the framework to a challenging realistic setting.
Registration
Registration for this webinar is free to both Members of PSI and Non-Members.
Please click here to register.
Overview
This is the fourth in the series* of webinars from The Estimands Academy for Trial Teams. We will build on the concepts and case studies previously discussed, recognizing the benefits of following the estimand framework (ICH E9 (R1)). A case study in heart failure will be presented from the perspective of multiple stakeholders. Topics covered will include constructing estimands for different stakeholder questions of interest including how to develop transparent estimands for product labels.
The target outcomes are as follows:
• To apply the estimand framework to a challenging realistic setting
• To appreciate the different stakeholder views when determining estimands
• To understand the relative merits of different strategies for intercurrent events
• Understanding implementation challenges and possible solutions
To view the flyer for this event, please click here.
Speaker Details
Speaker
Biography
Judith Anzures-Cabrera
Judith Anzures-Cabrera is a data scientist at Roche. She is part of the Estimands Implementation Working Group where she leads the Training sub-team.
Nikhil Kamath
Nikhil Kamath is Group Medical Director and Global Development Leader within Global Product Development Immunology, Infectious Disease, and Ophthalmology at Roche.
Antonia Morga
Antonia Morga is a Global Health Economics and Outcome Research Director. She co-leads the EIWG team on HTAs and RWE studies and is part of EFPIA HTA Working Group.
David Wright
David Wright is Head of Statistical Innovation at AstraZeneca, previously worked for the MHRA and led the revision of the CHMP guideline on missing data in confirmatory clinical trials.
Sue McKendrick
Sue McKendrick is a Statistical Science Director leading the cross-functional Estimand Working Group at PPD and is also a member of the EIWG training 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.
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 webinar brings together three bitesize complementary sessions to help PSI contributors create conference presentations and posters that communicate clearly and inclusively. Participants will explore how to refine their message, prepare materials effectively, and adopt practical habits that support confident, accessible delivery. A focused, supportive session designed to elevate every contribution.
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.
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.
Join our Health Technology Assessment (HTA) European Special Interest Group (ESIG) for a webinar on the strategic role of statisticians in the Joint Clinical Assessment (JCA). The introduction of the JCA marks a new era for evidence generation and market access in Europe. As HTA requirements become more harmonized and methodologically demanding, the role of statisticians has evolved far beyond data analysis. Today, statistical expertise is central to shaping clinical development strategies, designing robust comparative evidence, and ensuring that submissions withstand the scrutiny of EU-level assessors. In this webinar, we explore how statisticians contribute strategically to successful JCA outcomes.
Statisticians in the Age of AI: On Route to Strategic Partnership
A 90-minute webinar featuring two case studies from Bayer and Roche demonstrating how statisticians successfully integrated into AI programs, followed by interactive discussion on strategies for elevating statistical expertise in the AI era.
Enhancing Clinical Study Reporting with the Estimand Framework
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.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
GSK - Statistics Director - Vaccines and Infectious Disease
We are seeking an experienced and visionary Statistics Director to join our Team and lead strategic statistical innovation across GSK’s Vaccines and Infectious Disease portfolio.
As a Senior Biostatistician I at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
As a Statistical Scientist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
We have an exciting opportunity for an Associate Director, Biostatistics to join a passionate team within Advanced Quantitative Sciences – Full Development.
: 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).
We are looking for Senior Statistical Programmers in the UK to join Veramed, where you'll deliver high-impact programming solutions in an FSP-style capacity, while advancing your career in a supportive, growth-driven environment.