Jennifer Clark Nelson, PhD

“As national statistical leaders, we promote the use of rigorous methods that enhance drug and vaccine safety monitoring in the United States.”

Jennifer Clark Nelson, PhD

Director, Biostatistics; Senior Investigator, Kaiser Permanente Washington Health Research Institute
Affiliate Professor of Biostatistics, University of Washington

Jen.Nelson@kp.org
206-287-2004

Curriculum vitae (CV)

Biography

Jennifer Clark Nelson, PhD, is a senior investigator and biostatistician with expertise in methods to assess drug and vaccine safety and effectiveness for studies that use electronic health care data.

Dr. Nelson has provided national statistical leadership and strategic direction for the U.S. Food and Drug Administration (FDA)’s Sentinel Initiative, an active surveillance system for monitoring the safety of all FDA-regulated medical products after they have reached the market. She also leads safety research within the Centers for Disease Control and Prevention (CDC)-sponsored Vaccine Safety Datalink (VSD), a national collaboration involving 13 health care organizations that has monitored immunization safety in the United States since 1990. Her CDC service has also included membership on the Advisory Committee on Immunization Practices (ACIP) COVID-19 Vaccines Working group to help inform recommendations on the use of these vaccines in the U.S.

As part of both the VSD and Sentinel projects, Dr. Nelson has worked with her Kaiser Permanente Washington Health Research Institute (KPWHRI) colleagues Andrea Cook, PhD, and Brian Williamson, PhD, to pilot and scale up innovative sequential monitoring, machine learning, and natural language processing approaches that 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) childhood vaccine put some of these ideas into practice and was selected as one of the American Journal of Epidemiology’s 10 best articles of the year. She and her clinical KPWHRI research partner, Lisa Jackson, MD, MPH, also led the CDC’s surveillance effort to proactively monitor the safety of the new herpes zoster vaccine for adults (Shingrix).

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 the UW, she and Dr. Cook co-founded the Seattle Symposium on Health Care Data Analytics, a conference designed to confront challenges and promote learning from electronic health record data. In 2009, Dr. Nelson earned the VSD’s Margarette Kolczak Award for outstanding contributions in biostatistics and epidemiology in vaccine safety. She is also a fellow of the American Statistical Association.

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
Aging & Dementia

Biostatistics; statistical issues in longitudinal observational cohort studies
Cardiovascular Health

Recent publications

Cook AJ, Wellman RD, Marsh T, Tiwari RC, Nguyen MD, Russek-Cohen E, Peng Y, Nelson JC Estimating Risk Differences Using Large Healthcare Data Networks for Medical Product Post-Market Safety Outcomes in a Distributed Data Setting and Allowing for Active Post-Market Surveillance 2026 Mar;45(6-7):e70440. doi: 10.1002/sim.70440. PubMed

Stein AB, Williams JTB, Hurley LP, Breslin K, Kurlandsky K, Hambidge SJ, Nelson JC, Fuller CC, Crane B, Hanson KE, Glenn SC, Jazwa A, Reifler LM Accuracy of COVID-19 vaccination Self-report compared with data from VSD electronic health Records for Pregnant Women and non-pregnant Adults, 2021-2022 2026 Feb 5;195(2):515-523 doi:10.1093/aje/kwaf112. doi: 10.1093/aje/kwaf112. Epub 2025-05-29. PubMed

Williamson BD, Krakauer C, Johnson E, Gruber S, Shepherd BE, van der Laan MJ, Lumley T, Lee H, Hernández-Muñoz JJ, Zhao F, Dutcher SK, Desai R, Simon GE, Shortreed SM, Nelson JC, Shaw PA Assessing Treatment Effects in Observational Data With Missing Confounders: A Comparative Study of Practical Doubly-Robust and Traditional Missing Data Methods 2026 Feb;45(3-5):e70366. doi: 10.1002/sim.70366. PubMed

McClure DL, Hanson KE, Sundaram ME, Kieke BA, Duffy J, McNeil MM, Glanz JM, Irving SA, Williams JTB, Kharbanda EO, Xu S, Zerbo O, Nelson JC, Belongia EA, Weintraub ES Incident Epilepsy and Vaccination Status or Vaccine Aluminum Exposure in Children Under Age 4 2026 Jan 19 doi: 10.1016/j.jpeds.2026.115004. Epub 2026-01-19. PubMed

Hurley LP, Kurlandsky K, Breslin K, Stein A, Hambidge SJ, Shoup JA, Reifler LM, Daley MF, Lewin B, Goddard K, Henninger ML, Nelson JC, Vazquez-Benitez G, Hanson KE, Fuller CC, Williams JTB Attitudes and beliefs regarding COVID-19 and COVID-19 Omicron booster vaccine among adults in the vaccine safety datalink, 2022-2023 2025 Dec;21(1):2467548. doi: 10.1080/21645515.2025.2467548. Epub 2025-04-03. PubMed

Williams JTB, Kurlandsky K, Breslin K, Cruz H, Stein A, Shoup JA, Reifler LM, Daley MF, Lewin B, Goddard K, Henninger ML, Nelson JC, Vazquez-Benitez G, Hanson KE, Fuller CC, Hambidge SJ Religious Service Attendance, COVID-19 Vaccine Attitudes, and COVID-19 Vaccination Status: A Vaccine Safety Datalink Member Survey, 2022-2023 2025 Oct;4(5):100404. doi: 10.1016/j.focus.2025.100404. Epub 2025-07-30. PubMed

Li K, Emerman I, Cook AJ, Fireman BH, Sundaram M, Tseng HX, Weintraub ES, Yu O, Nelson JL, Shi X Using Double Negative Controls to Adjust for Healthy User Bias in a Recombinant Zoster Vaccine Safety Study 2025 Sep 3;194(9):2641-2649 doi:10.1093/aje/kwae439. doi: 10.1093/aje/kwae439. Epub 2024-11-26. PubMed

Zerbo O, Modaressi S, Fireman B, Ross P, Goddard K, Nelson J, Glanz J, Irving SA, Lewin B, DeSilva M, Hambidge SJ, Sundaram ME, Klein NP Risk of Immune Thrombocytopenic Purpura Recurrence Following Second Measles-Containing Vaccine Dose 2025 Aug;156(2). doi: 10.1542/peds.2025-070931. PubMed

Wyss R, van der Laan M, Gruber S, Shi X, Lee H, Dutcher SK, Nelson JC, Toh S, Russo M, Wang SV, Desai RJ, Lin KJ Note on targeted learning with an undersmoothed Lasso propensity score model for large-scale covariate adjustment in health care database studies 2025 May 7 doi: 10.1093/aje/kwaf024. Epub 2025-02-07. PubMed

Sheth SS, Vazquez-Benitez G, DeSilva MB, Zhu J, Seburg EM, Denoble AE, Daley MF, Getahun D, Klein NP, Vesco KK, Irving SA, Nelson JC, Williams JTB, Hambidge SJ, Donahue JG, Lipkind HS, Kharbanda EO Coronavirus Disease 2019 (COVID-19) Vaccination and Spontaneous Abortion 2025 May 2;146(1):129-137. doi: 10.1097/AOG.0000000000005904. Epub 2025-05-02. PubMed