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 Vaccine Safety Technical Work 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 David Carrell, 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, lead 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

Getahun D, Liu IA, Sy LS, Glanz JM, Zerbo O, Vazquez-Benitez G, Nelson JC, Williams JT, Hambidge SJ, McLean HQ, Irving SA, Weintraub ES, Qian L. Safety of the seasonal influenza vaccine in 2 successive pregnancies. JAMA Netw Open. 2024;7(9):e2434857. doi: 10.1001/jamanetworkopen.2024.34857. PubMed

Yih WK, Duffy J, Su JR, Bazel S, Fireman B, Hurley L, Maro JC, Marquez P, Moro P, Nair N, Nelson J, Smith N, Sundaram M, Vasquez-Benitez G, Weintraub E, Xu S, Shimabukuro T. Tinnitus after COVID-19 vaccination: Findings from the vaccine adverse event reporting system and the Vaccine Safety Datalink. Am J Otolaryngol. 2024 Jul 30;45(6):104448. doi: 10.1016/j.amjoto.2024.104448. [Epub ahead of print]. PubMed

Malden DE, Liu IA, Qian L, Sy LS, Lewin BJ, Asamura DT, Ryan DS, Bezi C, Williams JTB, Kaiser R, Daley MF, Nelson JC, McClure DL, Zerbo O, Henninger ML, Fuller CC, Weintraub ES, Saydah S, Tartof SY. Post-COVID conditions following COVID-19 vaccination: a retrospective matched cohort study of patients with SARS-CoV-2 infection. Nat Commun. 2024;15(1):4101. doi: 10.1038/s41467-024-48022-9. PubMed

Hazlehurst B, Carrell DS, Bann MA, Nelson J, Gruber S, Slaughter M, Cronkite DJ, Ball R, Floyd JS. Finding uncoded anaphylaxis in electronic health records to estimate the sensitivity of ICD10 codes. Am J Epidemiol. 2024 May 16:kwae063. doi: 10.1093/aje/kwae063. [Epub ahead of print]. PubMed

Daley MF, Reifler LM, Shoup JA, Glanz JM, Lewin BJ, Klein NP, Kharbanda EO, McLean HQ, Hambidge SJ, Nelson JC, Naleway AL, Weintraub ES, McNeil MM, Razzaghi H, Singleton JA. Influenza vaccination accuracy among adults: Self-report compared with electronic health record data. Vaccine. 2024;42(11):2740-2746. doi: 10.1016/j.vaccine.2024.03.052. Epub 2024 Mar 25. PubMed

Williams JTB, Kurlandsky K, Breslin K, Durfee MJ, Stein A, Hurley L, Shoup JA, Reifler LM, Daley MF, Lewin BJ, Goddard K, Henninger ML, Nelson JC, Vazquez-Benitez G, Hanson KE, Fuller CC, Weintraub ES, McNeil MM, Hambidge SJ. Attitudes toward COVID-19 vaccines among pregnant and recently pregnant individuals. JAMA Netw Open. 2024;7(4):e245479. doi: 10.1001/jamanetworkopen.2024.5479. 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. Targeted learning with an undersmoothed lasso propensity score model for large-scale covariate adjustment in healthcare database studies. Am J Epidemiol. 2024 Mar 21:kwae023. doi: 10.1093/aje/kwae023. [Epub ahead of print]. PubMed

Mossa-Basha M, Andre JB, Yuh E, Hunt D, LaPiana N, Howlett B, Krakauer C, Crane P, Nelson J, DeZelar M, Meyers K, Larson E, Ralston J, Mac Donald CL. Comparison of brain imaging and physical health between research and clinical neuroimaging cohorts of ageing. Br J Radiol. 2024;97(1155):614-621. doi: 10.1093/bjr/tqae004. PubMed

Desai RJ, Wang SV, Sreedhara SK, Zabotka L, Khosrow-Khavar F, Nelson JC, Shi X, Toh S, Wyss R, Patorno E, Dutcher S, Li J, Lee H, Ball R, Dal Pan G, Segal JB, Suissa S, Rothman KJ, Greenland S, Hernán MA, Heagerty PJ, Schneeweiss S. Process guide for inferential studies using healthcare data from routine clinical practice to evaluate causal effects of drugs (PRINCIPLED): considerations from the FDA Sentinel Innovation Center. BMJ. 2024;384:e076460. doi: 10.1136/bmj-2023-076460. PubMed

Markowitz LE, Hopkins RH Jr, Broder KR, Lee GM, Edwards KM, Daley MF, Jackson LA, Nelson JC, Riley LE, McNally VV, Schechter R, Whitley-Williams PN, Cunningham F, Clark M, Ryan M, Farizo KM, Wong HL, Kelman J, Beresnev T, Marshall V, Shay DK, Gee J, Woo J, McNeil MM, Su JR, Shimabukuro TT, Wharton M, Keipp Talbot H. COVID-19 Vaccine Safety Technical (VaST) Work Group: Enhancing vaccine safety monitoring during the pandemic. Vaccine. 2024 Feb 9:S0264-410X(23)01505-0. doi: 10.1016/j.vaccine.2023.12.059. [Epub ahead of print]. PubMed