ASSOCIATION OF GENERAL CLINICAL RESEARCH CENTER STATISTICIANS August 7-8, 2004 InterContinental Toronto Centre 255 Front Street West Meetings: Caledon Meals: Oakville Saturday, August 7 11:30 – 12:30 Lunch 12:30 − 12:40 Welcome 12:40 − 2:10 2:10 − 2:20 An Introduction to the Bootstrap Tim Hesterberg, Ph.D., Insightful Corp. Discussion 2:20 − 2:40 Break 2:40 − 3:30 Top 10 Statistical Books That No Busy GCRC Statistician Should Be Without Robert Oster, Ph.D., Univeristy of Alabama, Birmingham Discussion 3:30 − 3:40 3:40 − 4:40 Summary and Discussion of “Information Integration – The Next Frontier” Workshop, held Oct. 29-30, 2003 in Bethesda, MD Joyce Niland, Ph.D., City of Hope National Medical Center 4:40 − 5:30 GCRC Business 7:00 Dinner: Club Lucky (Kit Kat Too) 117 John Street Toronto, Ontario, Canada Phone: 416-977-8890 Sunday, August 8 7:30 − 8:15 Breakfast 8:15 − 9:15 Data Monitoring Committees Mary Foulkes, Ph.D., FDA Discussion 9:15 − 9:25 9:25 − 10:15 10:15 − 10:25 Bootstrap Methods using Estimating Functions Jack Kalbfleisch, Ph.D., Univeristy of Michigan Discussion 10:25 − 10:40 Break 10:40 − 11:40 11:40 − 11:50 Enhancements to the Statistical Software in SAS 9.1 Maura Stokes, DrPH, SAS Institute Discussion 11:50 − 12:00 Final Business 12:00 − 1:00 Lunch Our Speakers Tim Hesterberg, Ph.D. is the lead author of the "S+Resample" package for bootstrapping, permutation tests, jackknife, and other resampling procedures, and is lead author of "Bootstrap Methods and Permutation Tests" (2003) (see below), and numerous technical and pedagogical articles; see www.insightful.com/Hesterberg/bootstrap. He is a Research Scientist at Insightful Corp, taught at Franklin & Marshall and St. Olaf Colleges, and was an Operations Research Analyst at Pacific Gas & Electric Co. He is chair-elect of the Statistical Computing Section of the A.S.A., is on the Executive Board of the Interface Foundation, and is an associate editor of the Journal of Computational and Graphical Statistics. His Ph.D. is in Statistics from Stanford, where he studied under Brad Efron. Robert A. Oster, Ph.D., is the Biostatistician of the General Clinical Research Center (GCRC) at the University of Alabama at Birmingham (UAB). He is also Research Assistant Professor in the Medical Statistics Section of the UAB Department of Medicine, and is Associate Scientist and Biostatistician in the UAB Comprehensive Cancer Center. Prior to joining UAB in 2001, Dr. Oster held faculty positions at the Morehouse School of Medicine (1996 - 2001), and at the University of Miami School of Medicine (1995 - 1996). He has also served as a consultant to contract research organizations, and has worked for the federal government (Department of Defense). Dr. Oster received his Ph.D. in Biostatistics from the University of Cincinnati in 1995 and his M.S. in Statistics from the University of Kentucky in 1986. His research interests include design and analysis of clinical trials, categorical data analysis, and longitudinal data analysis. Dr. Oster is currently the Chair of the Section on Teaching of Statistics in the Health Sciences of the American Statistical Association, and is President-Elect of the Association of GCRC Statisticians. Joyce Niland, Ph.D., has been the Director of Biostatistics at City of Hope National Medical Center since 1988, and Chairs the Division of Information Sciences, founded in 1998 to join Biostatistics with a new Department of Biomedical Informatics. She is Professor in the Beckman Research Institute at City of Hope, and holds a joint appointment in USC’s School of Medicine. Dr. Niland received her Bachelors degree in Human Biology from Stanford University in 1975, a Masters degree in Physical Therapy from University of Southern California (USC) in 1978, a second Masters in Biometry from USC in 1979, and her doctorate in Biometry from USC in 1984. In 1996 Dr. Niland received a 2-year planning grant in information integration from the National Library of Medicine (NLM), followed by a 5-year implementation grant in 1998. In 2001 City of Hope received a grant from the National Center for Research Resources (NCRR) to develop Fully Integrated Research Standards and Technology (FIRST). Recently Dr. Niland was appointed as a member of the NCRR’s Biomedical Informatics Expert Panel. Dr. Niland currently is Vice President of the ASA. Mary A. Foulkes, Ph.D., is the Deputy Director of the Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA. She has published in both the statistical and medical literature on topics such as clinical trial design, analysis of longitudinal data, and data monitoring committees. Dr. Foulkes is also currently a Visiting Scholar with the Johns Hopkins University Bloomberg School of Public Health Department of Biostatistics. She has held a variety of positions in academia, private industry and government. In each of those capacities, she has participated in the design, conduct, interim monitoring, analysis and reporting of numerous randomized, controlled clinical trials in cardiovascular disease, neurological disorders, oncology therapies, HIV prevention and therapy, and vaccine efficacy. She serves on a number of Data Monitoring Committees for NIH and VA-sponsored trials. Dr. Foulkes is a Fellow of the American Statistical Association, and is currently the Statistics Section Secretary of the American Association for the Advancement of Science. Jack Kalbfleisch, Ph.D. is Professor of Biostatistics and Chair of the Department of Biostatistics. He received his Ph.D. in statistics in 1969 from the University of Waterloo. He was Assistant Professor in the Department of Statistics at the State University of New York at Buffalo (197073) and on faculty at the University of Waterloo (1973-2002). At Waterloo, he served as Chair of the Department of Statistics and Actuarial Science (1984-1990) and as Dean of the Faculty of Mathematics (1990-1998). He has held visiting appointments as Professor at the University of Washington, the University of Michigan, the University of California at San Francisco, the University of Auckland, and the National University of Singapore. He has worked in various areas of statistics and biostatistics including failure time and survival analysis, likelihood methods of inference, bootstrapping and estimating equations, mixture and mixed effects models and medical applications. Maura Stokes, DrPH, received her doctorate from the Department of Biostatistics at the University of North Carolina-Chapel Hill in 1986. She is presently R&D Director of the Statistical Applications Department at SAS Institute, where she has worked since 1985. Map from hotel to Restaurant Club Lucky (Kit Kat Too) 117 John Street InterContinental Toronto Centre 225 Front Street West