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

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 2024 Feb 12;384:e076460. doi: 10.1136/bmj-2023-076460. Epub 2024-02-12. PubMed

Qian L, Sy LS, Hong V, Glenn SC, Ryan DS, Nelson JC, Hambidge SJ, Crane B, Zerbo O, DeSilva MB, Glanz JM, Donahue JG, Liles E, Duffy J, Xu S Impact of the COVID-19 Pandemic on Health Care Utilization in the Vaccine Safety Datalink: Retrospective Cohort Study 2024 Jan 23;10:e48159. doi: 10.2196/48159. Epub 2023-12-12. PubMed

Daley MF, Reifler LM, Shoup JA, Glanz JM, Naleway AL, Nelson JC, Williams JTB, McLean HQ, Vazquez-Benitez G, Goddard K, Lewin BJ, Weintraub ES, McNeil MM, Razzaghi H, Singleton JA Racial and ethnic disparities in influenza vaccination coverage among pregnant women in the United States: The contribution of vaccine-related attitudes 2023 Dec;177:107751. doi: 10.1016/j.ypmed.2023.107751. Epub 2023-11-04. PubMed

Katherine Yih W, Daley MF, Duffy J, Fireman B, McClure DL, Nelson JC, Qian L, Smith N, Vazquez-Benitez G, Weintraub E, Williams JTB, Xu S, Maro JC Safety signal identification for COVID-19 bivalent booster vaccination using tree-based scan statistics in the Vaccine Safety Datalink 2023 Aug 14;41(36):5265-5270. doi: 10.1016/j.vaccine.2023.07.010. Epub 2023-07-19. PubMed

Vazquez-Benitez G, Haapala JL, Lipkind HS, DeSilva MB, Zhu J, Daley MF, Getahun D, Klein NP, Vesco KK, Irving SA, Nelson JC, Williams JTB, Hambidge SJ, Donahue J, Fuller CC, Weintraub ES, Olson C, Kharbanda EO COVID-19 Vaccine Safety Surveillance in Early Pregnancy in the United States: Design Factors Affecting the Association Between Vaccine and Spontaneous Abortion 2023 Aug 4;192(8):1386-1395. doi: 10.1093/aje/kwad059. Epub 2023-03-16. PubMed

DeSilva MB, Haapala J, Vazquez-Benitez G, Boyce TG, Fuller CC, Daley MF, Getahun D, Hambidge SJ, Lipkind HS, Naleway AL, Nelson JC, Vesco KK, Weintraub ES, Williams JTB, Zerbo O, Kharbanda EO Medically Attended Acute Adverse Events in Pregnant People After Coronavirus Disease 2019 (COVID-19) Booster Vaccination 2023 Jul;142(1):125-129. doi: 10.1097/AOG.0000000000005241. Epub 2023-05-11. PubMed

Kharbanda EO, Haapala J, Lipkind HS, DeSilva MB, Zhu J, Vesco KK, Daley MF, Donahue JG, Getahun D, Hambidge SJ, Irving SA, Klein NP, Nelson JC, Weintraub ES, Williams JTB, Vazquez-Benitez G COVID-19 Booster Vaccination in Early Pregnancy and Surveillance for Spontaneous Abortion 2023 May;6(5):e2314350. doi: 10.1001/jamanetworkopen.2023.14350. Epub 2023-05-01. PubMed

Wu Y, Rosenberg DE, Greenwood-Hickman MA, McCurry SM, Proust-Lima C, Nelson JC, Crane PK, LaCroix AZ, Larson EB, Shaw PA Analysis of the 24-h activity cycle: An illustration examining the association with cognitive function in the Adult Changes in Thought study 2023 Mar 27;14:1083344. doi: 10.3389/fpsyg.2023.1083344. Epub 2023-03-27. PubMed

Nelson JC, Ulloa-Pérez E, Yu O, Cook AJ, Jackson ML, Belongia EA, Daley MF, Harpaz R, Kharbanda EO, Klein NP, Naleway AL, Tseng HF, Weintraub ES, Duffy J, Yih WK, Jackson LA Active Post-Licensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data 2023 Feb;192(2):205-216. doi: 10.1093/aje/kwac170. Epub 2022-10-04. PubMed

Carrell DS, Gruber S, Floyd JS, Bann MA, Cushing-Haugen KL, Johnson RL, Graham V, Cronkite DJ, Hazlehurst BL, Felcher AH, Bejan CA, Kennedy A, Shinde MU, Karami S, Ma Y, Stojanovic D, Zhao Y, Ball R, Nelson JC Improving Methods of Identifying Anaphylaxis for Medical Product Safety Surveillance Using Natural Language Processing and Machine Learning 2023 Feb;192(2):283-295. doi: 10.1093/aje/kwac182. Epub 2022-11-04. PubMed