Event

Making Estimands Work - Practical Approaches with Implementation in Data Standards

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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.

Speaker details

SpeakerBiography

Shahida Tamboli, Sr. Manager, Biostatistics - Fortrea

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.

Alexandra Cochinaire, Standard Implementation Lead, Johnson & Johnson

Standards Implementation Lead at Johnson & Johnson with experience in statistics, programming, clinical data standards, and estimands, helping study teams achieve high-quality and consistent standards implementation from protocol development through analysis.


Xiaohan Zou, Director, Statistical Programming, BMS

Director in Statistical Programming at Bristol Myers Squibb. She is a co-author of the PHUSE white paper on implementing estimands in industry standards

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