David S.
Director, Biostatistics @Omeros Corporation
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WORK HISTORY
Director, Biostatistics @Omeros Corporation
San Diego, CA, US
Statistical Lead on late phase clinical studies, reporting directly to VP of Biometrics. • Statistical Program Lead on all phase clinical studies for ravulizumab (a monoclonal antibody) for treatment of the rare autoimmune hemolytic anemia disease paroxysmal nocturnal hemoglobinuria (PNH)o Manage and review deliverables (TLFs, CRFs, randomization specification, etc.) from internal and external partnerso Responsible for all statistical aspects of clinical studieso Wrote SAP for two Phase clinical trials within 10 weeks of start date- Specified return-to-baseline imputation (based precedent) for analysis of primary endpoint and secondary endpoints - Guided and contributed to response to FDA information requests• Statistical Program Lead on early phase treatment for Cocaine Use Disorder (CUD).o Specify, review and approve work by external CRO
EDUCATION
Rice University
PhD, Statistics
SKILLS
ABOUT DAVID S.
Forward-thinking leader and expert biostatistician, advocating for innovative statistical methods and processes through collaboration with FDA statisticians and reviewers. Actively involved in industry working groups shaping policy and guidelines for data use and analysis, with engagement in discussions with external KOLs. Experienced in managing and mentoring a team of highly skilled statisticians. Experienced with NDA, BLA, PMA, de novo and 510(k) submissions.Expertise includes- Interdisciplinary Project Leadership- Regulatory Submissions- Statistical Methods- Bayesian Analysis- Adaptive Designs- SAS- R- Team Management
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