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Susan Duke

Mathematical Statistician, OB, OTS, CDER
Silver Spring, MD
Susan became involved in safety related industry-wide graphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG. She is currently a Mathematical Statistician reviewer in CDER and member of a cross-functional safety monitoring WG co-sponsored by DIA and ASA Biopharm. Co-author of several presentations and publications on safety graphics, safety monitoring and benefit-risk structured thinking/assessment, her goal is to use quantitative thinking and methods in the ever-evolving field of safety assessment and benefit-risk evaluation during drug development, for making quality, data-informed decisions based on what's best for patients.