Mary F. Johnson, PhD has served as a statistical consultant to pharmaceutical clients for over 25 years, assisting in the design of drug development programs and advising clients on statistical and regulatory aspects of NDA/PLA submissions for a wide variety of therapeutic indications. Dr. Johnson previously led biostatistical operations at the global contract research organizations PharmaNet and Covance. She spent eight years at the FDA's Center for Drug Evaluation and Review (CDER), working as a group leader and as a statistical reviewer in the Division of Biometrics. She has a thorough knowledge of regulatory guidelines and processes, and has helped numerous clients develop efficient and statistically sound research programs to gain rapid marketing approval for their products.

A brief version of Dr. Johnson's CV

A list of Phase II and Phase III clinical trials in which Dr. Johnson has participated