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 Mentoring 2026
Date: Ongoing 6 month cycle beginning late April/early May 2026
Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
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: Effective Leadership – the keys to growing your leadership capabilities
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation.
The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication.
The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication.
The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.
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.
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.
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 are currently looking for a Postdoctoral Research Fellow, Statistics (full-time, 3-year fixed-term) to join the team based in our office in London, United Kingdom.
We have an exciting opportunity for an Associate Director, Biostatistics to join a passionate team within Advanced Quantitative Sciences – Full Development.
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.