Meijuan Li, Ph.D.

U.S. Food an Drug Administration

Dr. Meijuan Li is chief of Diagnostic Statistics Branch II in the Division of Biostatistics of the Center for Devices and Radiologic Health (CDRH) at the U.S. Food and Drug Administration (FDA). Her branch covers all in vitro diagnostic devices and some in vivo diagnostic and therapeutic devices submitted to CDRH.

Dr. Li has extensive regulatory statistical review experience including many cutting edge genetic/genomic diagnostic devices, and is a leading statistical expert in the area of companion diagnostics. She has published numerous manuscripts in various areas including Bayesian statistics, survival analysis, missing data, and personalized medicine. She has been manuscript referee for various statistical journals, and serves as an editorial board member for two statistical journals and as an FDA technical contact for the Clinical and Laboratory Standards Institute. 

Dr. Li received her doctorate in biostatistics from the University of Minnesota