Daniel O. Scharfstein

Affiliate

Expert

Daniel O. Scharfstein

Education

Sc.D. and M.S., biostatistics, Harvard School of Public Health; M.S., operations research, Georgia Institute of Technology; B.S., economics and applied science, University of Pennsylvania

Summary of Experience

Professor Scharfstein is a professor of Biostatistics at the Johns Hopkins Bloomberg School of Public Health. He is an expert in the design, monitoring, and analysis of randomized clinical trials, as well as observational studies. His particular research focus is on methods for reporting the results of clinical studies in the presence of potential selection bias primarily caused by missing or censored data, non-compliance, or non-random treatment assignment. He regularly consults with the pharmaceutical industry on statistical issues related to the regulatory approval of drugs and devices, and has served as an expert and provided depositions in a number of legal cases involving the safety and efficacy of drugs and devices. Professor Scharfstein also frequently sits on data and safety monitoring boards for clinical trials and has served on the NIAID Therapeutics Trials Data and Safety Monitoring Committee. He recently was a member of the National Academy of Sciences Panel, sponsored by the FDA, which produced the report “The Prevention and Treatment of Missing Data in Clinical Trials.” Professor Scharfstein is a fellow of the American Statistical Association, a recipient of the 1999 George W. Snedecor Award for Best Paper in Biometry, and a recipient of the 2010 Distinguished Alumni Award from the Department of Biostatistics at Harvard School of Public Health.

AG Contacts

Pierre Y. Cremieux