Daniel O. Scharfstein

Professor and Chief, Division of Biostatistics; Professor, Department of Population Health Sciences; and Adjunct Professor, Department of Orthopaedics and Department of Family and Preventive Medicine, University of Utah School of Medicine
Daniel O. Scharfstein


Sc.D. and M.S., biostatistics, Harvard School of Public Health; M.S., operations research, Georgia Institute of Technology

Summary of Experience

Professor Scharfstein is a biostatistician with expertise in the design, monitoring, and analysis of randomized clinical trials and observational studies. His research focuses on methods of reporting the results of clinical studies in which missing or censored data, non-compliance, or non-random treatment assignment may have resulted in selection bias. He has testified at deposition and trial in a number of litigation matters involving drug and medical device safety and efficacy in and outside the US. In addition, Professor Scharfstein regularly consults to the pharmaceutical industry, advising on statistical issues related to the regulatory approval of drugs and medical devices. He has served on multiple data safety monitoring boards for clinical trials, including for the National Institute of Allergy and Infectious Diseases. Professor Scharfstein is the principal biostatistician for the Major Extremity Trauma Research Consortium, which conducts multicenter clinical research studies relevant to the treatment and outcomes of orthopedic trauma sustained in the military. Professor Scharfstein is a fellow of the American Statistical Association, a recipient of the ASA’s George W. Snedecor Award for best paper in biometry, and a recipient of the Harvard T.H. Chan School of Public Health Department of Biostatistics’ Lagakos Distinguished Alumni Award. He has received multiple teaching excellence awards for his classes on probability and statistical theory.

AG Contacts

Pierre Y. Cremieux
Jee-Yeon Lehmann

Provided Expert Testimony