Dr. Zibman brings over a decade’s experience in the design and analysis of clinical trials of diagnostic devices in the regulatory setting. She worked at the FDA for over a decade, where she reviewed regulatory submissions of in vitro diagnostic and radiological devices. While there she conducted research and presented on topics including digital pathology, wearable devices, and AI/ML devices. She has developed and led mentoring programs for statisticians both for the FDA and for the Medical Devices and Diagnostics section of the American Statistical Association (ASA-MDD). She has also served as a board member of ASA-MDD and provided training to FDA staff on statistical principles.
Dr. Zibman graduated with highest honors from Brandeis University and holds a doctorate in statistics from The University of Chicago.
Overview
Dr. Zibman brings biostatistical expertise to MCRA where she is responsible for clinical trial design, data analysis, and regulatory strategy as regards to the use of statistical methods in the evaluation of diagnostic devices in particular those relating to in vitro diagnostics, radiology, and digital health. She develops and reviews statistical analysis plans prior to clinical studies and is responsible for describing statistical methods and study results following study completion. She assists clients in anticipating and responding to requests from regulatory agencies at all stages of the regulatory process and serves on Data Safety Monitoring Boards. In her capacity as Lead Biostatistician for clients’ projects Dr. Zibman ensures that clients deploy the optimal statistical methods for demonstrating the performance of their device and for obtaining regulatory approval.