Cong Han
Head of Clinical Biometrics at Astellas Pharma
- Role
- Vice President Head of Clinical Biometrics at Astellas Pharma
- Location
- Fairfax, VA, US
- LinkedIn followers
- 500 followers
About Cong Han
More than twenty years of pharmaceutical industry experience in the design, analysis, and evaluation of clinical development programs and clinical trials in multiple therapeutic areas (gastroenterology, cardio-renal and metabolic diseases, women’s health, infectious diseases, neurologic and muscular disorders) and across modalities of small molecules, monoclonal antibodies, vaccines, gene therapies, and cell therapiesExtensive experience interacting with FDA, EMA, and other regulatory agencies (e.g, Health Canada, SwissMedic, Australia TGA, and (co-)rapporteurs)Participation (as company representative) in two PhRMA Limited-Duration Key Issue Teams (adaptive designs and non-inferiority)
Experience
Vice President Head of Clinical Biometrics
Jul 2025 — Present
Lead a global team responsible for clinical statistics, statistical methodology and innovation, statistical programming, safety data science, and clinical modeling and analytics
Education
University of Chinese Academy of Sciences
MS, Industrial Psychology
University of Minnesota
PhD, Biostatistics (Minor: Statistics)
Peking University
BS, Psychology
University of Minnesota
MA, Biological Psychopathology
Skills
- Clinical Development
- Clinical Trials
- Drug Development
- Design of Experiments
- Due Diligence
- Adaptive Design
- Bayesian Statistics
- Group Sequential Design
- Missing Data Handling
- Multiplicity
- Meta-Analysis
- Non-Inferiority Trials
- R
- Sas
- Vaccines
- Diabetes
- Clinical Research
- Oncology
- Pharmaceutical Industry
- Statistics
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