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overview Jennifer Clark Nelson, PhD, is a senior investigator and biostatistician with expertise in methods to assess drug and vaccine safety and effectiveness. She is particularly interested in addressing methodological challenges that arise in post-marketing drug and vaccine safety studies that use large observational health care databases. Dr. Nelson provides national statistical leadership as a methods core lead and senior statistician for the Food and Drug Administration (FDA)’s Sentinel Initiative, an active surveillance system for monitoring the safety of all FDA-regulated medical products. She also leads methodological research within the Centers for Disease Control and Prevention-sponsored Vaccine Safety Datalink (VSD), a national collaboration involving 10 managed care organizations that has monitored immunization safety in the United States since 1990. As part of both the VSD and Sentinel projects, Dr. Nelson works with her Kaiser Permanente Washington Health Research Institute (KPWHRI) colleague Andrea Cook, PhD to improve statistical methods for post-marketing drug and vaccine safety surveillance that leverage electronic data across multiple large health care systems. Their goal is to develop new sequential testing approaches that will rapidly and accurately identify adverse events not detected in pre-licensure studies. Her 2013 study of the safety of a pentavalent combination DTaP-IPV-Hib (Pentacel) vaccine put these ideas into practice and was selected as one of the 10 best articles of the year by the American Journal of Epidemiology and the Society for Epidemiologic Research. Dr. Nelson is an affiliate professor in biostatistics at the University of Washington (UW) and has been KPWHRI’s director of biostatistics since 2014. In collaboration with UW, she and Dr. Cook co-founded and organized the Seattle Symposium on Health Care Data Analytics, a conference designed to confront challenges and promote learning from electronic data to advance health and health care. In 2009, Dr. Nelson earned the VSD’s Margarette Kolczak Award for outstanding contributions in biostatistics and epidemiology in the field of vaccine safety. Before joining KPWHRI, Dr. Nelson served for four years as the deputy director of the Multi-Ethnic Study of Atherosclerosis (MESA) Coordinating Center at the UW.

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