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DIA DIRECT: Study and Data Integrity Considerations for Clinical Trials Impacted by COVID-19

The fourth in our series of DIA DIRECT: COVID-19 Webinars!

Presenters

Christine  Fletcher, MSc

Christine Fletcher, MSc

VP/Head, Speciality and Primary Care Statistics, GlaxoSmithKline, United Kingdom

Chrissie is the VP Speciality & Primary Care Statistics at GSK. Chrissie has worked in the Pharmaceutical Industry for over 30 years and has experience of developing and commercialising new medicines in a variety of therapeutic areas across all phases of clinical development. Chrissie is actively engaged in Statistical societies, Pharmaceutical trade associations and initiatives relating to the Pharmaceutical Industry. She is currently the Chair of the Statisticians in the Pharmaceutical Industry (PSI), the EFPIA lead for the Innovation in Clinical Trials Pillar, a working group in the Clinical Research Expert Group, she is one of the PSI representatives on the EFSPI Council and she is the lead for the EFSPI Statistics Leaders Forum.

Daniel  Li

Daniel Li

Vice President, Cell Therapy Biostatistics, Bristol-Myers Squibb, United States

R. Daniel Meyer

R. Daniel Meyer

Executive Director, Rare Disease Statistics Head, Pfizer, United States

Bohdana  Ratitch, PhD, MSc

Bohdana Ratitch, PhD, MSc

Principal Statistician, Bayer, Canada

Bohdana is a Principal Statistician Bayer. She has over 15 years of experience in biopharmaceutical industry including statistical methodology research and consulting, with numerous publications in missing data, estimands, subgroup identification, and machine learning. She is a co-author of two books, “Estimands, Estimators and Sensitivity Analysis in Clinical Trials” (2020) and “Clinical Trials with Missing Data: a Guide for Practitioners” (2014). Bohdana is a member of the DIA SWG on Missing data and EFSPI Subgroup Special Interest Group. Bohdana holds a BSs in Applied Mathematics from Ivan Franko National University of Lviv, Ukraine, and a MSc and a PhD in Machine Learning from McGill University in Montreal, Canada.

David J. Wright, PhD, MS

David J. Wright, PhD, MS

Head of Statistical Innovation, AstraZeneca, United States

David has worked as a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for 10 years. He has been heavily involved in the recent revision of the CHMP Missing Data guideline.

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