Ruthie Davi BS, MA, PhD

Ruthie Davi has worked in the area of pharmaceutical product development, and specifically the FDA, over 20 years. In her current position as a Director in Data Science at Medidata Solutions, she is part of a team focused on providing centralized systematic monitoring and other novel clinical trial tools. Ruthie has held numerous positions within the FDA, including Statistical Reviewer, Team Leader, and Deputy Director, where she implemented innovative statistical methods and made recommendations for clinical trial designs tailored to the regulatory setting. She has conducted the statistical review, represented the Agency at Advisory Committee meetings, and provided recommendations regarding FDA marketing approval for numerous New Drug and Biologic Licensing Applications. With a particular interest in pediatric clinical trials, she was an active member of FDA's Pediatric Review Committee. Ruthie holds a Ph.D. in biostatistics from George Washington University.