Estimands Implementation Working Group – Training Subteam in Collaboration with PHUSE
Date: Tuesday 29 September 2026 Time: 14:00 - 15:30 BST Location: Online via Zoom
Who is this event intended for?
This webinar is aimed primarily at statistical programmers, with useful insights for data managers, statisticians, medical writers, clinicians and regulators. It will be assumed attendees already have a background understanding of estimands and intercurrent events.
What is the benefit of attending?
Understand the core challenges posed by intercurrent event (ICE) handling strategies to data collection, analysis, and documentation
Illustrate how to build Analysis Datasets supporting estimators, including the implementation of the ADICE dataset and tracing impacted datapoints using the ICCyEzz approach
Recognize the best practices for end-to-end documentation, specifically how to detail estimand implementations in the Clinical Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
Overview
The ICH E9(R1) estimand framework has important implications not only for trial design and analysis, but also for data collection, data flow, and analysis dataset creation. This webinar will focus on implementation of the estimand framework using data standards, with particular emphasis on the considerations needed to support estimation of estimands and traceability of intercurrent events.
Building on the PHUSE white paper Implementation of ICH E9(R1) Estimands Framework using Data Standards, the session will discuss practical approaches across the clinical data flow, from CRFs and SDTM to ADaM and reviewer documentation. Topics will include how to capture and map information relevant to intercurrent events, considerations for ADaM datasets including ADICE, and approaches to documenting estimand implementation clearly and consistently. A case study will illustrate how these principles can be applied in practice.
Registration
This webinar is free to attend for PSI Members & Non-Members. To register for this event, please click here.
Statistical Science Director, Biostatistics at Thermo Fisher Scientific. Sue has over 30 years’ experience of statistical consultancy and chairs the Training Subteam of the Estimand Implementation Working Group (EIWG).
Senior Manager of Biostatistics at Fortrea. PHUSE working group co‑lead for ICH E9(R1) estimands. Expertise includes imputation methods, sensitivity analyses, and advanced statistical methodologies.
Elisa Gomez Valderas, Director, Eli Lilly
Director in Statistics at Eli Lilly, with expertise in innovative clinical trial design, clinical development and access-focused research. She is a co-author of the PHUSE white paper on implementing estimands in industry standards.
Director in Statistical Programming at Bristol Myers Squibb. She is a co-author of the PHUSE white paper on implementing estimands in industry standards
Scientific Meetings
Making Estimands Work - Practical Approaches with Implementation in Data Standards
Estimands Implementation Working Group – Training Subteam in Collaboration with PHUSE
Date: Tuesday 29 September 2026 Time: 14:00 - 15:30 BST Location: Online via Zoom
Who is this event intended for?
This webinar is aimed primarily at statistical programmers, with useful insights for data managers, statisticians, medical writers, clinicians and regulators. It will be assumed attendees already have a background understanding of estimands and intercurrent events.
What is the benefit of attending?
Understand the core challenges posed by intercurrent event (ICE) handling strategies to data collection, analysis, and documentation
Illustrate how to build Analysis Datasets supporting estimators, including the implementation of the ADICE dataset and tracing impacted datapoints using the ICCyEzz approach
Recognize the best practices for end-to-end documentation, specifically how to detail estimand implementations in the Clinical Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
Overview
The ICH E9(R1) estimand framework has important implications not only for trial design and analysis, but also for data collection, data flow, and analysis dataset creation. This webinar will focus on implementation of the estimand framework using data standards, with particular emphasis on the considerations needed to support estimation of estimands and traceability of intercurrent events.
Building on the PHUSE white paper Implementation of ICH E9(R1) Estimands Framework using Data Standards, the session will discuss practical approaches across the clinical data flow, from CRFs and SDTM to ADaM and reviewer documentation. Topics will include how to capture and map information relevant to intercurrent events, considerations for ADaM datasets including ADICE, and approaches to documenting estimand implementation clearly and consistently. A case study will illustrate how these principles can be applied in practice.
Registration
This webinar is free to attend for PSI Members & Non-Members. To register for this event, please click here.
Statistical Science Director, Biostatistics at Thermo Fisher Scientific. Sue has over 30 years’ experience of statistical consultancy and chairs the Training Subteam of the Estimand Implementation Working Group (EIWG).
Senior Manager of Biostatistics at Fortrea. PHUSE working group co‑lead for ICH E9(R1) estimands. Expertise includes imputation methods, sensitivity analyses, and advanced statistical methodologies.
Elisa Gomez Valderas, Director, Eli Lilly
Director in Statistics at Eli Lilly, with expertise in innovative clinical trial design, clinical development and access-focused research. She is a co-author of the PHUSE white paper on implementing estimands in industry standards.
Director in Statistical Programming at Bristol Myers Squibb. She is a co-author of the PHUSE white paper on implementing estimands in industry standards
Training Courses
Making Estimands Work - Practical Approaches with Implementation in Data Standards
Estimands Implementation Working Group – Training Subteam in Collaboration with PHUSE
Date: Tuesday 29 September 2026 Time: 14:00 - 15:30 BST Location: Online via Zoom
Who is this event intended for?
This webinar is aimed primarily at statistical programmers, with useful insights for data managers, statisticians, medical writers, clinicians and regulators. It will be assumed attendees already have a background understanding of estimands and intercurrent events.
What is the benefit of attending?
Understand the core challenges posed by intercurrent event (ICE) handling strategies to data collection, analysis, and documentation
Illustrate how to build Analysis Datasets supporting estimators, including the implementation of the ADICE dataset and tracing impacted datapoints using the ICCyEzz approach
Recognize the best practices for end-to-end documentation, specifically how to detail estimand implementations in the Clinical Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
Overview
The ICH E9(R1) estimand framework has important implications not only for trial design and analysis, but also for data collection, data flow, and analysis dataset creation. This webinar will focus on implementation of the estimand framework using data standards, with particular emphasis on the considerations needed to support estimation of estimands and traceability of intercurrent events.
Building on the PHUSE white paper Implementation of ICH E9(R1) Estimands Framework using Data Standards, the session will discuss practical approaches across the clinical data flow, from CRFs and SDTM to ADaM and reviewer documentation. Topics will include how to capture and map information relevant to intercurrent events, considerations for ADaM datasets including ADICE, and approaches to documenting estimand implementation clearly and consistently. A case study will illustrate how these principles can be applied in practice.
Registration
This webinar is free to attend for PSI Members & Non-Members. To register for this event, please click here.
Statistical Science Director, Biostatistics at Thermo Fisher Scientific. Sue has over 30 years’ experience of statistical consultancy and chairs the Training Subteam of the Estimand Implementation Working Group (EIWG).
Senior Manager of Biostatistics at Fortrea. PHUSE working group co‑lead for ICH E9(R1) estimands. Expertise includes imputation methods, sensitivity analyses, and advanced statistical methodologies.
Elisa Gomez Valderas, Director, Eli Lilly
Director in Statistics at Eli Lilly, with expertise in innovative clinical trial design, clinical development and access-focused research. She is a co-author of the PHUSE white paper on implementing estimands in industry standards.
Director in Statistical Programming at Bristol Myers Squibb. She is a co-author of the PHUSE white paper on implementing estimands in industry standards
Journal Club
Making Estimands Work - Practical Approaches with Implementation in Data Standards
Estimands Implementation Working Group – Training Subteam in Collaboration with PHUSE
Date: Tuesday 29 September 2026 Time: 14:00 - 15:30 BST Location: Online via Zoom
Who is this event intended for?
This webinar is aimed primarily at statistical programmers, with useful insights for data managers, statisticians, medical writers, clinicians and regulators. It will be assumed attendees already have a background understanding of estimands and intercurrent events.
What is the benefit of attending?
Understand the core challenges posed by intercurrent event (ICE) handling strategies to data collection, analysis, and documentation
Illustrate how to build Analysis Datasets supporting estimators, including the implementation of the ADICE dataset and tracing impacted datapoints using the ICCyEzz approach
Recognize the best practices for end-to-end documentation, specifically how to detail estimand implementations in the Clinical Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
Overview
The ICH E9(R1) estimand framework has important implications not only for trial design and analysis, but also for data collection, data flow, and analysis dataset creation. This webinar will focus on implementation of the estimand framework using data standards, with particular emphasis on the considerations needed to support estimation of estimands and traceability of intercurrent events.
Building on the PHUSE white paper Implementation of ICH E9(R1) Estimands Framework using Data Standards, the session will discuss practical approaches across the clinical data flow, from CRFs and SDTM to ADaM and reviewer documentation. Topics will include how to capture and map information relevant to intercurrent events, considerations for ADaM datasets including ADICE, and approaches to documenting estimand implementation clearly and consistently. A case study will illustrate how these principles can be applied in practice.
Registration
This webinar is free to attend for PSI Members & Non-Members. To register for this event, please click here.
Statistical Science Director, Biostatistics at Thermo Fisher Scientific. Sue has over 30 years’ experience of statistical consultancy and chairs the Training Subteam of the Estimand Implementation Working Group (EIWG).
Senior Manager of Biostatistics at Fortrea. PHUSE working group co‑lead for ICH E9(R1) estimands. Expertise includes imputation methods, sensitivity analyses, and advanced statistical methodologies.
Elisa Gomez Valderas, Director, Eli Lilly
Director in Statistics at Eli Lilly, with expertise in innovative clinical trial design, clinical development and access-focused research. She is a co-author of the PHUSE white paper on implementing estimands in industry standards.
Director in Statistical Programming at Bristol Myers Squibb. She is a co-author of the PHUSE white paper on implementing estimands in industry standards
Webinars
Making Estimands Work - Practical Approaches with Implementation in Data Standards
Estimands Implementation Working Group – Training Subteam in Collaboration with PHUSE
Date: Tuesday 29 September 2026 Time: 14:00 - 15:30 BST Location: Online via Zoom
Who is this event intended for?
This webinar is aimed primarily at statistical programmers, with useful insights for data managers, statisticians, medical writers, clinicians and regulators. It will be assumed attendees already have a background understanding of estimands and intercurrent events.
What is the benefit of attending?
Understand the core challenges posed by intercurrent event (ICE) handling strategies to data collection, analysis, and documentation
Illustrate how to build Analysis Datasets supporting estimators, including the implementation of the ADICE dataset and tracing impacted datapoints using the ICCyEzz approach
Recognize the best practices for end-to-end documentation, specifically how to detail estimand implementations in the Clinical Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
Overview
The ICH E9(R1) estimand framework has important implications not only for trial design and analysis, but also for data collection, data flow, and analysis dataset creation. This webinar will focus on implementation of the estimand framework using data standards, with particular emphasis on the considerations needed to support estimation of estimands and traceability of intercurrent events.
Building on the PHUSE white paper Implementation of ICH E9(R1) Estimands Framework using Data Standards, the session will discuss practical approaches across the clinical data flow, from CRFs and SDTM to ADaM and reviewer documentation. Topics will include how to capture and map information relevant to intercurrent events, considerations for ADaM datasets including ADICE, and approaches to documenting estimand implementation clearly and consistently. A case study will illustrate how these principles can be applied in practice.
Registration
This webinar is free to attend for PSI Members & Non-Members. To register for this event, please click here.
Statistical Science Director, Biostatistics at Thermo Fisher Scientific. Sue has over 30 years’ experience of statistical consultancy and chairs the Training Subteam of the Estimand Implementation Working Group (EIWG).
Senior Manager of Biostatistics at Fortrea. PHUSE working group co‑lead for ICH E9(R1) estimands. Expertise includes imputation methods, sensitivity analyses, and advanced statistical methodologies.
Elisa Gomez Valderas, Director, Eli Lilly
Director in Statistics at Eli Lilly, with expertise in innovative clinical trial design, clinical development and access-focused research. She is a co-author of the PHUSE white paper on implementing estimands in industry standards.
Director in Statistical Programming at Bristol Myers Squibb. She is a co-author of the PHUSE white paper on implementing estimands in industry standards
Careers Meetings
Making Estimands Work - Practical Approaches with Implementation in Data Standards
Estimands Implementation Working Group – Training Subteam in Collaboration with PHUSE
Date: Tuesday 29 September 2026 Time: 14:00 - 15:30 BST Location: Online via Zoom
Who is this event intended for?
This webinar is aimed primarily at statistical programmers, with useful insights for data managers, statisticians, medical writers, clinicians and regulators. It will be assumed attendees already have a background understanding of estimands and intercurrent events.
What is the benefit of attending?
Understand the core challenges posed by intercurrent event (ICE) handling strategies to data collection, analysis, and documentation
Illustrate how to build Analysis Datasets supporting estimators, including the implementation of the ADICE dataset and tracing impacted datapoints using the ICCyEzz approach
Recognize the best practices for end-to-end documentation, specifically how to detail estimand implementations in the Clinical Study Data Reviewer's Guide (cSDRG) and Analysis Data Reviewer's Guide (ADRG)
Overview
The ICH E9(R1) estimand framework has important implications not only for trial design and analysis, but also for data collection, data flow, and analysis dataset creation. This webinar will focus on implementation of the estimand framework using data standards, with particular emphasis on the considerations needed to support estimation of estimands and traceability of intercurrent events.
Building on the PHUSE white paper Implementation of ICH E9(R1) Estimands Framework using Data Standards, the session will discuss practical approaches across the clinical data flow, from CRFs and SDTM to ADaM and reviewer documentation. Topics will include how to capture and map information relevant to intercurrent events, considerations for ADaM datasets including ADICE, and approaches to documenting estimand implementation clearly and consistently. A case study will illustrate how these principles can be applied in practice.
Registration
This webinar is free to attend for PSI Members & Non-Members. To register for this event, please click here.
Statistical Science Director, Biostatistics at Thermo Fisher Scientific. Sue has over 30 years’ experience of statistical consultancy and chairs the Training Subteam of the Estimand Implementation Working Group (EIWG).
Senior Manager of Biostatistics at Fortrea. PHUSE working group co‑lead for ICH E9(R1) estimands. Expertise includes imputation methods, sensitivity analyses, and advanced statistical methodologies.
Elisa Gomez Valderas, Director, Eli Lilly
Director in Statistics at Eli Lilly, with expertise in innovative clinical trial design, clinical development and access-focused research. She is a co-author of the PHUSE white paper on implementing estimands in industry standards.
Director in Statistical Programming at Bristol Myers Squibb. She is a co-author of the PHUSE white paper on implementing estimands in industry standards
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.
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.
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.
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.
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.
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.
What if your placement year meant more than observing from the sidelines? Join Novartis and spend 12 months working hands-on with real clinical trial and healthcare data, helping to advance medicines that could improve patients' lives.
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.
