Jesse Berlin, ScD
Vice President and Global Head, Epidemiology
Johnson & Johnson
Dr. Berlin received his doctorate in biostatistics from the Harvard School of Public Health in 1988. After spending 15 years as a faculty member at the University of Pennsylvania, in the Center for Clinical Epidemiology and Biostatistics, under the direction of Dr. Brian Strom, Jesse left Penn to join Janssen Research & Development as a Senior Director in Biostatistics. After two years, he was promoted to Vice President for Epidemiology. He now serves as Vice President of Epidemiology across all of Johnson & Johnson, with responsibility for pharmaceuticals, devices and consumer products. He has authored or coauthored over 230 publications in a wide variety of clinical and methodological areas, including papers on the study of meta-analytic methods as applied to both randomized trials and epidemiology. He served on an Institute of Medicine Committee that developed recommendations for the use of systematic reviews in clinical effectiveness research, and served on the Scientific Advisory Committee to the Observational Medical Outcomes Partnership, a public-private partnership aimed at understanding methodology for assessing drug safety in large, administrative databases. He served as a member of working group X for CIOMS (The Council for International Organizations of Medical Sciences), which has published guidelines for meta-analysis of drug safety data in the regulatory context. He was elected as a fellow of the American Statistical Association in 2004. In 2013, Dr. Berlin received the Lagakos Distinguished Alumni Award from the Department of Biostatistics at the Harvard School of Public Health.
Cepeda MS, Berlin JA, Glasser SC, Battisti WP, Schuemie M. Use of adjectives in abstracts when reporting results of randomized controlled trials from industry and academia. Drugs in R&D; 2015 (in press).
Madigan D, Stang PE, Berlin JA, et al. A Systematic Statistical Approach to Evaluating Evidence from Observational Studies. Annual Review of Statistics and Its Application. 2014;1(1):11-39.
Madigan D, Ryan PB, Schuemie M, et al. Evaluating the impact of database heterogeneity on observational study results. Am J Epidemiol. 2013 Aug 15;178(4):645-51. doi: 10.1093/aje/kwt010. Epub 2013 May 5.
Araujo M, Charles C, Weinstein R, McGuire J, Parikh-Das A, Du, Qiong, Zhang J, Berlin J, Gunsolley J. Meta-analysis of the effect of an essential oil-containing mouthrinse on gingivitis and plaque. The Journal of the American Dental Association 2015; (in press)
Wang Y, Berlin JA, Pinheiro J, Wilcox MA. Causal inference methods to assess safety upper bounds in randomized trials with noncompliance. Clinical Trials 2015 (in press).
Yuan Z, Levitan B, Burton P, Poulos C, Hauber AB, Berlin JA. Relative Importance of Benefits and Risks Associated with Antithrombotic Therapies for Acute Coronary Syndrome: Patient and Physician Perspectives. Current Medical Research & Opinion 2014;30(9):1733-41.
Levitan B, Yuan Z, Turpie AGG, Friedman RJ, Homering M, Berlin JA, Berkowitz SD, Weinstein RB, DiBattiste PM. Benefit-risk assessment of rivaroxaban versus enoxaparin for the prevention of venous thromboembolism after total hip or knee arthroplasty. Vascular Health and Risk Management 2014;10:1-11.
Von Korff M; Shortreed S; Saunders KW; LeResche L; Berlin JA; Stang P; Turner JA. Comparison of Back Pain Prognostic Risk Stratification Item Sets. The Journal of Pain 2014;15:81-89.
Turner JA, Shortreed SM, Saunders KW, LeResche L, Berlin JA, Von Korff M. Optimizing Prediction of Back Pain Outcomes. Pain. 2013 Aug;154(8):1391-401.
Berlin JA, Crowe BJ, Whalen E, Xia HA, Koro CE, Kuebler J. Meta-analysis of clinical trial safety data in a drug development program: answers to frequently asked questions. Clin Trials. 2013 Feb;10(1):20-31.
Cepeda MS, Fife D, Berlin JA, Mastrogiovanni G, Yuan Y. Characteristics of prescribers whose patients shop for opioids: Results from a cohort study. Journal of Opioid Management 2012; 8:285-91.
Committee on Standards for Systematic Reviews of Comparative Effectiveness Research (Berlin, J., a member). Finding What Works in Health Care: Standards for Systematic Reviews. Institute of Medicine. Jill Eden, Laura Levit, Alfred Berg, and Sally Morton, Editors.
Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, et al. (2009) The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration. J Clinical Epidemiology 2009; 62: e1-e34.
Crowe BJ, Xia HA, Berlin JA, Watson DJ, Shi H, Lin S, Kuebler J, Schriver RC, Santanello NC, Rochester G, Porter JB, Oster M, Mehrotra DV, Li Z, King EC, Harpur ES, Hall DB. Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team. Clinical Trials 2009; 6:430-440.
Moher D, Liberati A, Tetzlaff J, Altman DG. The PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. J Clinical Epidemiology 2009; 62:1006-1012.