DIA DIRECT: Study and Data Integrity Considerations for Clinical Trials Impacted by COVID-19
Presenters
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Christine Fletcher, MSc
- Vice President, Development Biostatistics
- GlaxoSmithKline, United Kingdom
Chrissie is an Executive Director Biostatistics in Global Biostatistical Science at Amgen. She is the Global Biostatistics TA Head for Cardiovascular, Metabolic, Neuroscience, Bone, Inflammation and Nephrology disease areas, the EU Regional Head for Biostatistics and leads a Health Technology Assessment (HTA) Biostatistics group. Chrissie has worked in the Pharmaceutical Industry for over 25 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.
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Daniel Li
- Vice President, Cell Therapy Biostatistics
- Bristol-Myers Squibb, United States
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R. Daniel Meyer
- Executive Director, Rare Disease Statistics Head
- Pfizer, United States
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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.
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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.
