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Areas of expertise: Biostatistics, Clinical Trial Methodology, Late-Stage Drug Development
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 started her career at FDA’s Center for Drug Evaluation and Review (CDER) where she spent 8 years as a group leader and statistical reviewer in the Division of Biometrics. Since then, she has built and led biostatistical operations at 2 global contract research organizations, Corning-Besselaar (now Covance) and PharmaNet (now Syneos). She is familiar with drug regulatory guidelines and processes, and has helped numerous clients develop efficient and statistically sound research programs to gain rapid marketing approval. Her work includes preparation and review of statistical analysis plans, study reports, regulatory submissions, and presentations to FDA advisory committees. She also serves on data safety monitoring boards and scientific advisory committees.
Dr. Johnson earned her PhD in biostatistics at Yale University and has authored dozens of publications and presentation for major journals and conferences. She also has a Master’s degree in epidemiology from the Yale School of Public Health, and a BS degree in Mathematics and Philosophy from Tufts University.