Freda Cooner

Background

About Freda Cooner

About 20 years of work experience with an extensive regulatory experience in FDA across different therapeutic areas in medical device, drugs and biologic, including cardiovascular, gastroenterology, anesthesia, pulmonary and inborn error metabolism (rare disease). Last three years at the FDA, serving as the statistician on the pediatric review committee (PeRC) while managing a review team. Overseeing all rare disease and pediatric applications during the last two years at the FDA. Contributions in multiple guidance drafting and advisory committee meetings. Industry experience includes both study statistician and project lead statistician in diabetes, as well as oncology projects. Familiar with project profile, trial design and conduct, CRO negotiation and regulatory submission preparation, along with protocol and SAP. Lead in DMC report activities, non-inferiority and long-term cardiovascular outcome trials, and collaboration with programmers on programming specifications. Active member in ASA Biopharmaceutical Section. Have been an executive committee and Regulatory-Industry Workshop steering committee member since 2015. Co-chaired 2016 ASA Biopharmaceutical Section Regulatory-Industry Workshop. Numerous presentations and session organization in professional meetings, including JSM, DIA and Workshop. Serving as an associate editor for Statistics in Biopharmaceutical Research journal. Research interests include Bayesian statistics, adaptive design, small sample size trials, pediatric studies, multiple testing procedures, missing data imputation, mater protocols, real-world evidence, safety evaluation and endpoints selection.