Susan S. Ellenberg, Ph.D.

Susan Ellenberg joined the biostatistics faculty at the University of Pennsylvania as Professor of Biostatistics
in the fall of 2004. Dr. Ellenberg directs the Biostatistics Core for the Penn Center for AIDS Research, and is also collaborating on projects in endocrinology, anesthesiology, breast cancer, pulmonary hypertension and HIV. Prior to arriving at Penn, Dr. Ellenberg held leadership positions at the National Institutes of Health and the Food and Drug Administration. Her areas of research have included surrogate endpoints for treatment effects in clinical trials, operational issues for data monitoring committees, clinical trial designs, adverse event monitoring, vaccine safety and special issues in cancer and AIDS trials. Dr. Ellenberg is a Fellow of the American Statistical Association, the Society for Clinical Trials and the American Association for the Advancement of Science, and is an elected member of the International Statistical Institute. She has served as President of the Eastern North American Region (ENAR) of the International Biometric Society, and of the Society for Clinical Trials. She also served on the Board of Trustees of the National Institute of Statistical Sciences, and chaired that Board from 2011-14. She is an Associate Editor of Clinical Trials and the Journal of the National Cancer Institute, and serves on the Advisory Board of Trials. Her book, Data Monitoring Committees in Clinical Trials: A Practical Perspective, co-authored with Drs. Thomas Fleming and David DeMets, was named Wiley Europe Statistics Book of the Year for 2002.
Dr. Ellenberg holds a a secondary appointment in the Department of Medical Ethics and Health Policy.

Selected Publications

  • Ellenberg SS and Temple R. Placebo-controlled trials and active control trials in the evaluation of new treatments. Part 2: Practical issues and specific cases. Annals of Internal Medicine 133:464-470, 2000.
  • Ellenberg SS and George SL. Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership? Statistics in Medicine 23:1503-1505, 2004.
  • Ellenberg SS, Foulkes MA, Midthun K and Goldenthal KL. Evaluating the safety of new vaccines: Summary of a workshop. American Journal of Public Health 95:800-807, 2005.
  • Berlin JA, Glasser SC, Ellenberg SS. Adverse event detection in drug development: recommendations and obligations beyond phase 3. American Journal of Public Health 98(8): 1366, Aug 2008.
  • Ellenberg SS. Accelerated approval of oncology drugs: Can we do better? JNCI 103:616-617, 2011.
  • Wan H, Ellenberg SS, Anderson K. Stepwise two-stage sample size adaptation. Statistics in Medicine 34:27-38, 2015.
  • Joffe S, Ellenberg SS. Methods and ethics in adaptively randomized trials. Clinical Trials 12:116-118, 2015.
  • Ellenberg SS , Culbertson R, Gillen DL, Goodman S, Schrandt S, Zirkle M. Data monitoring committees for pragmatic clinical trials. Clinical Trials, 12:530-536, 2015
    Fleming TR, Ellenberg SS. Evaluating interventions for Ebola: the need for randomized trials. Clinical Trials, 13:6-9, 2016
  • Snyder PJ, Bhasin,S, Cunningham GR, Matsumoto AM, Stephens-Shields, AJ, Cauley JA, Gill TM, Barrett-Connor E, Swerdloff RS, Wang C, Ensrud KE, Lewis CE, Farrar JT, Cella D, Rosen RC, Pahor M, Crandall JP, Molitch, ME, Cifelli D, Dougar D, FluhartyL, Resnick SM, Storer TW, Anton S, Basaria S, Diem SJ, Hou X, Mohler ER, Parsons JK, Wenger NK, Zeldow B, Landis JR, Ellenberg SS for The Testosterone Trials. Effects of testosterone treatment of older men. New England J Medicine, 374:611-24, 2016.