Jennifer Clark Nelson, PhD

“We develop new statistical methods to help researchers and policymakers improve drug and vaccine safety surveillance systems worldwide.”

Jennifer Clark Nelson, PhD

Senior Investigator and Director of Biostatistics, Kaiser Permanente Washington Health Research Institute


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.

Research interests and experience

  • Biostatistics

    Post-marketing drug and vaccine safety study design and analysis; secondary use and misuse of large electronic health care databases for medical research; vaccine effectiveness study methods; sequential testing in observational data settings; methods to assess interrater variability

  • Vaccines & Infectious Diseases

    Biostatistics; post-marketing vaccine safety study design and analysis; influenza vaccine effectiveness in the elderly; methodological issues in large multi-site health care database studies

  • Medication Use & Patient Safety

    Biostatistics; post-marketing drug and vaccine safety study design and analysis; safety signal detection methods; methodological issues in large, multi-site health care database studies

  • Cardiovascular Health

    Biostatistics; statistical issues in multi-site, longitudinal observational studies; coronary artery calcium CT scoring methods

Recent publications

McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Oral health 4 life: design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers. Contemp Clin Trials. 2017 Apr 12. pii: S1551-7144(16)30427-X. doi: 10.1016/j.cct.2017.04.003. [Epub ahead of print]. PubMed

Glass JE, Rathouz PJ, Gattis M, Joo YS, Nelson JC, Williams EC. Intersections of poverty, race/ethnicity, and sex: alcohol consumption and adverse outcomes in the United States. Soc Psychiatry Psychiatr Epidemiol. 2017 Mar 27. doi: 10.1007/s00127-017-1362-4. [Epub ahead of print]. PubMed

Gruber S, Chakravarty A, Heckbert SR, Levenson M, Martin D, Nelson JC, Psaty BM, Pinheiro S, Reich CG, Toh S, Walker AM. Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association. Pharmacoepidemiol Drug Saf. 2016 Jul 14. doi: 10.1002/pds.4065. [Epub ahead of print]. PubMed

Nelson JC, Wellman R, Yu O, Cook AJ, Maro JC, Ouellet-Hellstrom R, Boudreau D, Floyd JS, Heckbert SR, Pinheiro S, Reichman M, Shoaibi A. A synthesis of current surveillance planning methods for the sequential monitoring of drug and vaccine adverse effects using electronic health care data. EGEMS (Wash DC). 2016 Sep 6;4(1):1219. eCollection 2016. PubMed


Health Care Data Analytics Symposium

2nd Seattle Symposium on Health Care Data Analytics

October 23–25, 2016, Hyatt Olive 8 in downtown Seattle.

Vaccines & Infectious Diseases

New way to tackle vaccine hesitancy tested, found wanting

Group Health, WithinReach, Seattle Children’s, BestStart, Washington Department of Health partnered.

Read about it in News and Events.

Healthy Findings blog

Let’s Talk Vaccines—and the power of negative results

What we learned in new research on doctor-parent conversations about vaccines, from study coauthor Dr. David Grossman.