Laura Lee Johnson, Ph.D.

Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER).  Her division supports a wide variety of therapeutic areas many of which rely on less traditional methods to assess evidence.  She also works across FDA on patient focused drug development (PFDD), rare disease initiatives, COVID-19, and master protocol programs.  Prior to working at the FDA, Dr. Johnson spent over a decade at the U.S. National Institutes of Health working on and overseeing clinical research and research support programs including the CTSAs, PROMIS, and NIH Collaboratory.  She worked at both NCI and what is now known as NCCIH.  Dr. Johnson co-directs the NIH Principles and Practice of Clinical Research course.