Tianxi Cai, Ph.D.
Research Area: Risk Prediction, Biomarker Evaluation, High Dimensional Data Analysis, Model Selection and Validation, Personalized Medicine in Disease Diagnosis, Prognosis and Treatment, Semi-parametric methods, Survival Analysis.
Colin B. Begg, Ph.D.
Colin Begg is Head of the Department of Epidemiology and Biostatistics at Memorial Sloan-Kettering Cancer Center, a position he has held since 1989. He has conducted research on statistical methods in several areas of application, including clinical trials, epidemiology, health services research, meta-analysis and genetics/genomics.
Rebecca Betensky, Ph.D.
Dr. Rebecca Betensky is Professor of Biostatistics at Harvard School of Public Health and Biostatistician at Massachusetts General Hospital. She is Director of the Biostatistics Program at the Harvard Catalyst (CTSA) and the Harvard NeuroDiscovery Center. Her research focuses on methods for truncated and censored data, such as arise in settings in which there is biased sampling. These include studies that are sampled from cohort studies and clinical trials. She also works on methods for biomarker analyses, including the problem of the lack of a gold standard. Her collaborative research focuses mainly on neurological diseases.
Victor De Gruttola, Sc.D
Dr. De Gruttola received his DSc in 1986 from the Biostatistics Department at HSPH—the department for which he now serves as Chair. His research focuses on development of statistical methods required for appropriate public health response to the AIDS epidemic both within the US and internationally. The aspects of the epidemic on which he has worked include transmission of, and natural history of infection with, the Human Immunodeficiency Virus (HIV), as well as research on antiretroviral treatments, including the development and consequences of resistance to treatments. The broad goals of his research include developing treatment strategies that provide durable virologic suppression while preserving treatment options after failure, and evaluating the community-level impact of packages of prevention interventions, including antiviral treatment itself. He served as the Director of the Statistics and Data Analysis Center of the Adult Project of the AIDS Clinical Trials Group during the period in which highly active antiretroviral treatment was developed, and he was instrumental in designing and analyzing studies of the best means of providing such therapy.
David L. DeMets, Ph.D.
David L. DeMets is currently a Professor in the Department of Biostatistics and Medical Informatics at the University of Wisconsin – Madison. Since receiving his PhD in 1970, he has been active in the design, conduct, and analysis of clinical trials in several disease areas. Following a postdoctoral appointment at the National Institutes of Health (1970-72), he spent ten years (1972-1982) at the National Heart, Lung and Blood Institute at the National Institutes of Health where he was a member of and later became chief of the biostatistics branch. In 1982, he joined the University of Wisconsin and created the Department of Biostatistics and Medical Informatics where he served as Chair through June 2009. His research interests include the design, data monitoring and analysis of clinical trials, especially large Phase III randomized clinical trials. He is well known for his work on sequential statistical methods for monitoring interim data for early evidence of intervention benefit or possible harm.
Lisa LaVange, Ph.D.
Lisa M. LaVange, PhD, is Director of the Office of Biostatistics in the Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). She assumed this position in September, 2011 and as Director, oversees approximately 170 statistical reviewers and staff members involved in the development and application of statistical methodology for drug regulation.
Prior to joining the FDA, Dr. LaVange was Professor and Director of the Collaborative Studies Coordinating Center (CSCC) in the Department of Biostatistics, Gillings School of Global Public Health at the University of North Carolina at Chapel Hill (UNC). As CSCC Director, she served as Principal Investigator (PI) of the coordinating centers for several large-scale multi-center clinical trials, epidemiology studies, and patient registries, including the NHLBI-funded Hispanic Community Health Study/Study of Latinos (HCHS/SOL) and the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS) and the NIMH-funded Schizophrenia Trial Network. Before joining academia, Dr. LaVange spent 10 years in the pharmaceutical industry, serving as Vice-President of Biostatistics and Data Management for Inspire Pharmaceuticals, Inc., and Vice-President of Biostatistics for Quintiles, Inc. Her clinical trial and drug development experience spans the areas of cardiovascular and pulmonary disease, mental health, and ophthalmology. Her experience also includes 16 years in non-profit research at the Research Triangle Institute.
Dr. LaVange is a Fellow of the American Statistical Association and served as President of the Eastern North American Region of the International Biometric Society (2007). She is co-editor of the Journal of Pharmaceutical Statistics and editor-in-chief of the ASA-SIAM book series. Her research areas include methods for the design and analysis of clinical trials and complex sample surveys. She taught graduate courses at UNC in the areas of clinical trials, statistical consulting, and statistical leadership.
Lisa McShane, Ph.D.
Lisa M. McShane, Ph.D. is a mathematical statistician in the Biometric Research Branch at the National Cancer Institute (NCI) and has served as a statistical advisor to the Cancer Diagnosis Program and Cancer Therapy Evaluation Program on matters relating to use of tumor markers for prognosis, prediction, and disease-monitoring. She is a member of the NCI Program for the Assessment of Clinical Cancer Tests (PACCT) Strategy Group. Dr. McShane is an author of numerous statistical and biomedical papers, co-author of the REMARK guidelines for standardization of reporting of tumor marker prognostic studies, and co-author of a book "Statistical Design and Analysis of DNA Microarray Investigations".
Gene Pennello, Ph.D.
Dr. Gene A. Pennello is an FDA Team Leader and Mathematical Statistician in the Diagnostics Devices Branch, Division of Biostatistics, Center for Devices and Radiological Health. He has been with the Agency thirteen years. Before joining FDA, Gene was an NIH postdoctoral training fellow at the National Cancer Institute, Division of Cancer Epidemiology and Genetics. He earned his Ph.D. in Statistics in 1993 from Oregon State University. He also has Master's and Bachelor of Science degrees in Statistics and a Bachelor of Science degree in Computer Science and Mathematics from the University California at Davis. Dr. Pennello has experience in the FDA review of diagnostic imaging devices and in vitro diagnostic tests. In particular, he has considerable experience reviewing IVDs that measure biomarkers for prognostic or predictive claims. His statistical interests include Bayesian methods, multiple comparisons, and missing data.
Yougming Qu, Ph.D.
Yongming Qu received his BS and MS from China University of Science and Technology in 1994 and 1997. He received his PhD in Statistics from Iowa State University in 2002. He is currently a Research Advisor and a scientific leader in diabetes drug development at Eli Lilly, and an adjunct professor at Iowa State University. He has been active in applying and developing novel statistical methods in biopharmaceutical research. His statistical research areas include surrogate marker validation, measurement error models, missing data, propensity score estimation, nonparametric methods, survey sampling and novel clinical study designs.
Eric Rubin, M.D.
Dr. Rubin has focused on cancer drug development for over 20 years, initially as an oncology fellow and faculty member at the Dana-Farber Cancer Institute, then as a senior leader of the Cancer Institute of New Jersey. In 2008 Dr. Rubin was recruited to Merck Research Laboratories as Vice-President and Therapeutic Area Head of Oncology Clinical Development. In this role he oversees all clinical oncology research activities, including the application of molecular profiling and biomarker technologies to drug development.
Dr. Rubin has authored over 100 original, peer-reviewed publications and book chapters related to oncology clinical trials and drug development. He has served frequently as a member of NCI and American Cancer Society study sections, as well as on program committees for the American Association of Cancer Research and the American Society of Clinical Oncology. In addition, he serves on several editorial boards, including The Journal of Clinical Oncology and Investigational New Drugs, and is a deputy editor for Clinical Cancer Research.
Daniel J. Sargent, Ph.D.
Daniel J. Sargent, Ph.D. is the Ralph and Beverly Caulkins Professor of Cancer Research at the Mayo Clinic. He is Professor of Biostatistics and Oncology at the Mayo Clinic, is the Group Statistician for the Alliance for Clinical Trials in Oncology and the director of Cancer Center Statistics at the Mayo Clinic Comprehensive Cancer Center. He received his BS, MS, and PhD from the University of Minnesota, and has been at Mayo Clinic since graduating in 1996. Dr. Sargent co-chaired a joint NCI-EORTC committee on methodology for tumor marker studies, was a member of the FDA panel on endpoints for colon cancer clinical trials, and currently sits on the US NCI Clinical Trials Advisory Committee, which oversees all cancer clinical trials in the United States. Dr. Sargent is a chair or member of over 35 Data Safety and Monitoring Committees. Statistically, Dr. Sargent has published papers on innovative designs for Phase I, II, and III clinical trials as well as advances in survival analysis, meta-analysis, and designs for validating tumor biomarkers. Clinically, he has published extensively in colorectal cancer treatment in the elderly, optimal clinical trial endpoints, and prognostic and predictive biomarkers. He has authored over 230 peer-reviewed manuscripts, book chapters, editorials, and letters.
Jay Siegel, M.D.
Jay Siegel, M.D., is the Chief Biotechnology Officer for Johnson & Johnson and the Head of Pharmaceutical Global Regulatory Affairs for Janssen, the pharmaceutical companies of Johnson & Johnson. As Chief Biotechnology Officer, he leads an organization responsible for expanding and applying the Company's extensive capabilities in the discovery and development of protein- and cell-based products. The Global Regulatory Affairs organization provides regulatory support for pharmaceutical products in over 100 countries.
Dr. Siegel is actively engaged in policy development at the national and international levels in the regulatory, biotechnology, and clinical development arenas. He currently serves on the Executive Committee of the Board of Directors of the Biotechnology Industry Organization and the Executive Committee of the Clinical Trials Transformation Initiative.
Dr. Siegel joined Johnson & Johnson in 2003 as President, Centocor Research & Development, Inc., and subsequently added a variety of responsibilities for various companies and functions within J&J. Prior to joining Johnson & Johnson, he spent 20 years at the FDA Center for Biologics Evaluation & Research in positions of increasing responsibility regulating the biotechnology industry.
Dr. Siegel received a B.S. in Biology from California Institute of Technology and an M.D. from Stanford University. He trained in Internal Medicine at the University of California, San Francisco, and in Infectious Diseases and Immunology at Stanford University.
Dr. Siegel is recipient of numerous honors including the U.S. Public Health Service's highest honor, the Distinguished Service Medal and, twice, the HHS Secretary's Award for Distinguished Service. In 2011, he accepted the Prix Galien USA for Best Biotechnology Product – Stelara, whose development he led and oversaw. He has been elected to fellowship in the American College of Physicians and the Society for Clinical Trials.
He has authored numerous publications in the areas of clinical trial design, biotechnology, immunology, and drug development policy.
Janet Wittes, Ph.D.
Janet Wittes, Ph.D., is President of Statistics Collaborative, Inc. which she founded in 1990. Previously, she was Chief, Biostatistics Research Branch, National Heart, Lung, and Blood Institute (NHLBI) and on the faculty of the Department of Mathematical Science, Hunter College of the City University of New York. For the five-year term from 1994 through 1998, she was Editor in Chief of Controlled Clinical Trials. In 2006, she was awarded the Janet L. Norwood Award for Outstanding Achievement by a Woman in the Statistical Sciences.
Her research has focused on the design and analysis of randomized clinical trials, capture recapture methods in epidemiology, sample size recalculation problems in clinical studies, and incorporation of subjective outcomes in clinical trials. She is a coauthor of the monograph, "Statistical Monitoring of Clinical Trials - A Unified Approach" by Proschan, Lan, and Wittes. She is a member of many advisory committees for government and industry, including a large number of Data Monitoring Committees (DMCs). She is a Fellow of the American Statistical Association, the Society for Clinical Trials (SCT), the American Association for the Advancement of Science, and an elected member of the International Statistical Institute.
She received her A.B. in Mathematics from Radcliffe College (1964) and her M.A. and Ph.D. in Statistics from Harvard University (1965, 1970).