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 provides 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 further includes 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 works 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

Berrueta M, Ciapponi A, Bardach A, Cairoli FR, Castellano FJ, Xiong X, Stergachis A, Zaraa S, Meulen AS, Buekens P; Scoping Review Collaboration Group. Maternal and neonatal data collection systems in low- and middle-income countries for maternal vaccines active safety surveillance systems: a scoping review. BMC Pregnancy Childbirth. 2021 Mar 17;21(1):217. doi: 10.1186/s12884-021-03686-9. PubMed

Panagiotakopoulos L, McCarthy NL, Tepper NK, Kharbanda EO, Lipkind HS, Vazquez-Benitez G, McClure DL, Greenberg V, Getahun D, Glanz JM, Naleway AL, Klein NP, Nelson JC, Weintraub ES Evaluating the Association of Stillbirths After Maternal Vaccination in the Vaccine Safety Datalink 2020 Dec;136(6):1086-1094. doi: 10.1097/AOG.0000000000004166. PubMed

Fireman B, Gruber S, Zhang Z, Wellman R, Nelson JC, Franklin J, Maro J, Murray CR, Toh S, Gagne J, Schneeweiss S, Amsden L, Wyss R Consequences of depletion of susceptibles for hazard ratio estimators based on propensity scores 2020 Nov;31(6):806-814. doi: 10.1097/EDE.0000000000001246. PubMed

McClure JB, Anderson ML, Krakauer C, Blasi P, Bush T, Nelson J, Catz SL Impact of a novel oral health promotion program on routine oral hygiene among socioeconomically disadvantaged smokers: results from a randomized semi-pragmatic trial 2020 May 20;10(2):469-477. doi: 10.1093/tbm/ibz009. PubMed

Shi X, Miao W, Nelson JC, Tchetgen EJT Multiply robust causal inference with double-negative control adjustment for categorical unmeasured confounding 2020 Apr;82(2):521-540. doi: 10.1111/rssb.12361. Epub 2020-01-22. PubMed

Shi X, Wellman R, Heagerty PJ, Nelson JC, Cook AJ Safety surveillance and the estimation of risk in select populations: Flexible methods to control for confounding while targeting marginal comparisons via standardization 2020 Feb 20;39(4):369-386. doi: 10.1002/sim.8410. Epub 2019-12-10. PubMed

Donahue JG, Kieke BA, Lewis EM, Weintraub ES, Hanson KE, McClure DL, Vickers ER, Gee J, Daley MF, DeStefano F, Hechter RC, Jackson LA, Klein NP, Naleway AL, Nelson JC, Belongia EA Near Real-Time Surveillance to Assess the Safety of the 9-Valent Human Papillomavirus Vaccine 2019 Dec;144(6). doi: 10.1542/peds.2019-1808. Epub 2019-11-18. PubMed

Cook AJ, Wellman RD, Marsh T, Shoaibi A, Tiwari R, Nguyen M, Boudreau D, Weintraub ES, Jackson L, Nelson JC Applying sequential surveillance methods that use regression adjustment or weighting to control confounding in a multi-site, rare event, distributed setting: Part 2 In-Depth Example of a re-analysis of the measles-mumps-rubella-varicella combination vacci 2019 Sep;113:114-122. doi: 10.1016/j.jclinepi.2019.04.019. Epub 2019-05-02. PubMed

Nelson JC, Ulloa-Pérez E, Bobb JF, Maro JC Leveraging the entire cohort in drug safety monitoring: Part 1 Methods for Sequential surveillance that use regression adjustment or weighting to control confounding in a multi-site, rare event, distributed data setting 2019 Aug;112:77-86. doi: 10.1016/j.jclinepi.2019.04.012. Epub 2019-05-18. PubMed

Tseng HF, Sy LS, Qian L, Liu IA, Mercado C, Lewin B, Tartof SY, Nelson J, Jackson LA, Daley MF, Weintraub E, Klein NP, Belongia E, Liles EG, Jacobsen SJ Pneumococcal Conjugate Vaccine Safety in Elderly Adults 2018 Jun;5(6):ofy100. doi: 10.1093/ofid/ofy100. Epub 2018-05-02. PubMed