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avatar for Susan Duke

Susan Duke

FDA
Mathematical Statistician, OB, OTS, CDER
Silver Spring, MD
Susanis is a Mathematical Statistician reviewer in CDER, assigned to pulmonary, allergy and critical care indications. She became involved in safety related industry-wide graphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG, which lead to subsequent interests in safety graphics, and use of estimands and benefit-risk for structured thinking and 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, and to use estimands to align the data assessment with the clinical objectives of the program, for making quality, data-informed decisions based on what's best for patients.