Jennifer L. Kirk received her doctorate in biostatistics from the University of Washington. After her Ph.D., she joined U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research as a statistical reviewer. She spent 5 years as a reviewer of clinical and CMC statistics for vaccines, allergenics, and live biotherapeutics. For the past four years, she has served as the Lead Mathematical Statistician in the Device and Non-Clinical Evaluation branch as the lead for the CMC statistics team. Her team provides statistical support to CBER’s product, manufacturing, and facilities reviewers for a wide range of biologics including, vaccines, allergenics, live biotherapeutics, cell and gene therapies, tissues, and therapeutic proteins.