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Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 8:30 AM - Apr 08, 2019 12:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Short Course 2: Data Monitoring

Instructors

Matthew  Downs, MPH

Matthew Downs, MPH

Statistical Scientist, Statistics Collaborative, Inc., United States

Matt Downs joined Statistics Collaborative, Inc. (SCI) in 1996. Since 1999, he has served as the independent reporting statistician to DMCs for multinational Phase 2 and 3 trials in a variety of indications. Matt received his MPH in Epidemiology and Biostatistics from the University of California, Berkeley.

Scott  Evans, PhD, MS

Scott Evans, PhD, MS

Professor and Founding Chair, Department of Biostatistics and Bioinformatics, George Washington University Milken Institute of Public Health, United States

Dr. Scott Evans is a Professor and Founding Chair of the Department of Biostatistics Bioinformatics and the Director of The Biostatistics Center at George Washington University. He is the: Director of the SDMC for the Antibacterial Resistance Leadership Group (ARLG); PI of the Coordinating Center for the ENICTO Consortium; Co-Chair of the Benefit-Risk Balance for Medicinal Products Working Group of the Council for International Organizations of Medical Sciences (CIOMS); and Editor of a mini-Series on DSMBs for the NEJM Evidence. He is a recipient of the Mosteller Statistician Award, the Zackin Distinguished Collaborative Statistician Award, the ASA's Founders Award, and is a Fellow of the ASA, SCT, ISI, and the IDSA.

Christopher B. Granger, MD

Christopher B. Granger, MD

Professor of Medicine; Director, Cardiac Intensive Care Unit, Duke University Medical Center, United States

Dr. Christopher Granger is a Professor of Medicine in the Division of Cardiology at Duke University and Director of the Cardiac Care Unit for the Duke University Medical Center. He has served on FDA advisory committees on an ad hoc basis. He is on the Board of External Experts of the National Heart, Lung and Blood Institute (NHLBI). Dr. Granger’s primary research interest is in the conduct and methodology of large randomized clinical trials in heart disease; he has co-authored more than 500 peer-reviewed manuscripts. He currently serves on a number of clinical trial steering committees and data safety monitoring committees.

Frank W. Rockhold, PhD, MSc

Frank W. Rockhold, PhD, MSc

Professor of Biostatistics, Duke Clinical Research Institute, Duke University Medical Center, United States

Frank is a full-time Professor of Biostatistics and Bioinformatics at Duke University Medical Center and Managing Partner of HunterRockhold, Inc., which provides strategic consulting to Industry and Government. His career includes senior positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer. He has held faculty appointments at six different universities, served as Chairman of CDISC, and is past president of the Society for Clinical Trials. Frank holds a BA in Statistics and an ScM and PhD in Biostatistics. Frank is a Fellow of the American Statistical Association, The Royal Statistical Society, and the Society for Clinical Trials and is widely published across a wide variety of research topics.

Janet Turk Wittes, PhD

Janet Turk Wittes, PhD

President, Statistics Collaborative Inc., United States

Janet Wittes is President of Statistics Collaborative, a company that consults on design of clinical trials. She has participated in many Data Safety Monitoring Committees for government and for industry. Her research deals with statistical monitoring of randomized trials.

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