About Us - Committees - Steering

Jianwen Cai, PhD - Bio and Pubs
University of North Carolina at Chapel Hill
Project 1 Leader

Dr. Cai is Professor and Vice Chair of Biostatistics at the University of North Carolina at Chapel Hill. Dr. Cai is Co-Director of the Biostatistics Service of North Carolina Translational and Clinical Sciences Institute at the University of North Carolina at Chapel Hill and directs the methodology component within that service. Her expertise is in design and analysis of clinical trials and observational studies, longitudinal and survival data analysis, analysis of correlated responses, and missing data/measurement error methods. She is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics and an Associate Editor for Biometrics, Lifetime Data Analysis, Statistics in Biosciences, and the Journal of the American Statistical Association Application and Case Studies Section. She was 2013 Chair of the American Statistical Association Biometrics Section and will be 2016 Easter North American Region president.

Marie Davidian, PhD - Bio and Pubs
North Carolina State University
Principal Investigator, Core A Co-Director, Core B Co-Director, Project 4 Co-Leader

Dr. Davidian is William Neal Reynolds Professor of Statistics and Coordinator for the Chancellor's Faculty Excellence Program's Personalized Medicine Discovery Faculty Cluster at North Carolina State University, and is Adjunct Professor of Biostatistics and Bioinformatics at Duke. Her methodological research expertise is in development of techniques for analysis of data from clinical trials and observational studies in chronic disease, for discovery of optimal dynamic treatment regimes and causal inference, for handling of missing and mismeasured data, and for analysis of longitudinal data. Through her adjunct position, she collaborates with researchers at Duke Clinical Research Institute on challenges in cardiovascular disease and cancer research, and during her time at Harvard School of Public Health, she was senior statistician on numerous clinical studies of HIV infection for the AIDS Clinical Trials Group. Dr. Davidian is currently a co-investigator in the Biostatistics Service of the North Carolina Translational and Clinical Sciences Institute at the University of North Carolina at Chapel Hill. She was 2013 President and is a Fellow of the American Statistical Association. In addition, she is a Fellow of the Institute of Mathematical Statistics, and the American Association for the Advancement of Science, and is an elected member of the International Statistical Institute. She has been Executive Editor of Biometrics since 2006 and was that journal's Coordinating Editor in 2000-20002..

Shannon Holloway, PhD - Bio and Pubs
North Carolina State University
Core B Director

Dr. Holloway is trained as a theoretical physicist, having received her Ph.D. from the University of Illinois at Urbana-Champaign in 2004. She served as a Post-doctoral Research Associate and a Staff Scientist in the Theoretical Division of Los Alamos National Laboratory. Throughout her education and career, Dr. Holloway’s research interests focused on developing and implementing sophisticated numerical models of complex fundamental processes. She has developed software applications for her personal research interests, large collaborative projects, private-sector clients, and publicly available commercial research tools.

Joseph G. Ibrahim, PhD - Bio and Pubs
University of North Carolina at Chapel Hill
Co-Principal Investigator, Project 2 Leader

Dr. Ibrahim is Alumni Distinguished Professor of Biostatistics, Professor of Statistics and Operations Research, and Member of the Lineberger Comprehensive Cancer Center at the University of North Carolina at Chapel Hill. Dr. Ibrahim's areas of research focus are Bayesian inference, missing data problems, clinical trials, and cancer genomics, and is Project Director/Principal Investigator of two NIH grants for developing statistical methodology related to cancer and genomics research. Dr. Ibrahim is the Director of the Biostatistics and Data Management Core at the Lineberger Comprehensive Cancer Center and is the biostatistical core leader of an NIH Specialized Program of Research Excellence grant in breast cancer. With over 19 years experience working in cancer clinical trials, Dr. Ibrahim directs the University of North Carolina Center for Innovative Clinical Trials. He is currently the Editor of the Journal of the American Statistical Association Applications and Case Studies Section. He has also published two books on Bayesian survival analysis and Monte Carlo methods in Bayesian computation, and is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics and an elected member of the International Statistical Institute.

Michael R Kosorok, PhD - Bio and Pubs
University of North Carolina at Chapel Hill
Principal Investigator (Contact), Core A Director, Project 4 Co-Leader

Dr. Kosorok is W. R. Kenan, Jr. Distinguished Professor and Chair of Biostatistics, Member of the Lineberger Comprehensive Cancer Center, and Professor of Statistics and Operations Research at the University of North Carolina at Chapel Hill. Dr. Kosorok is also Director of the Biostatistics Service of the North Carolina Translational and Clinical Sciences Institute. His expertise is in biostatistical methods for clinical trails and data mining and machine learning tools for high dimensional biomedical data, with a focus on cancer applications. He is also an expert in the theoretical properties underlying biostatistical methods, especially in the areas of empirical processes and semiparametric inference, and is author of a book on this topic. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and is an Associate Editor for the Annals of Statistics, the Journal of the American Statistical Association Theory and Methods Section, and the International Journal of Biostatistics.

Danyu Lin, PhD - Bio and Pubs
University of North Carolina at Chapel Hill
Project 3 Leader, Core B Co-Director

Dr. Lin is Dennis Gillings Distinguished Professor of Biostatistics and Member of the Lineberger Comprehensive Cancer Center at the University of North Carolina at Chapel Hill. Dr. Lin is an internationally-recognized leader in survival analysis and statistical genetics with 20 years of experience in cancer research, currently focused on pharmacogenomics in cancer. He received the American Public Health Association Mortimer Spiegelman Award in 1999 for top biostatistician under the age of 40 and is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics. Dr. Lin is an Associate Editor for Biometrika and is recipient of a Method to Extend Research in Time award from the National Institute of General Medical Sciences.

Kouros Owzar, PhD - Bio and Pubs
Duke University School of Medicine
Principal Investigator, Core A Co-Director, Core B Co-Director, Project 3 Co-Leader

Dr. Owzar is Professor of Biostatistics and Bioinformatics at Duke University School of Medicine, Director of Bioinformatics at the Duke Cancer Institute, and Director of Biostatistics for the Radiation Countermeasures Center of Research Excellence at Duke. His research is focused on the development of statistical methods and computational tools for investigating the role of heritability on cancer drug induced adverse events. Dr. Owzar is a member of the Duke Cancer Institute Executive Committee, lead statistician of the Alliance Pharmacogenomics and Population Pharmacology committee, and a co-investigator of the Global Alliance for Pharmacogenomics, a joint research program between the National Institutes of Health and the Center for Genomic Medicine in Japan at the RIKEN Institute.

Anastasios (Butch) Tsiatis, PhD - Bio and Pubs
North Carolina State University
Co-Principal Investigator, Project 4 Leader

Dr. Tsiatis is Gertrude M. Cox Distinguished Professor of Statistics at North Carolina State University and Adjunct Professor of Biostatistics and Bioinformatics at Duke. He is a leading expert in clinical trials, survival analysis, causal inference, dynamic treatment regimes, group sequential trials, and semiparametric inference and author of a book on the latter topic. His methodological research has been funded continuously on grants from the National Cancer Institute since 1983, and he is recipient of a Method to Extend Research in Time award from the National Institute of Allergy and Infectious Diseases. Dr. Tsiatis has served as Co-Editor of Biostatistics since 2009. He has a long history of involvement in cancer research. He was coordinating statistician for the Eastern Cooperative Oncology Group in 1982–1984 and a member of the data safety monitoring board for the Cancer and Leukemia Group B in 1999-2004. Dr. Tsiatis is a co-investigator in the Biostatistics Service of the North Carolina Translational and Clinical Sciences Institute at the University of North Carolina at Chapel Hill. He received the American Public Health Association Mortimer Spiegelman Award in 1986 and is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics and an elected member of the International Statistical Institute.

Xiaofei Wang, PhD - Bio and Pubs
Duke University School of Medicine
Co-Principal Investigator, Project 1 Co-Leader

Dr. Wang is Associate Professor of Biostatistics and Bioinformatics at Duke University. In the past ten years, he has been involved in the design and analysis of cancer clinical trials and translational studies in the Alliance. He serves as Associate Director of Biostatistics and the lead statistician for the Respiratory Committee of the Alliance. Dr. Wang’s methodological research is focused on the development of novel statistical methods for biomarker-integrated cancer clinical trials and for analyzing data from multiple sources subject to lack of generalizability and selection bias. He has been the Project Director/Principal Investigator for National Cancer Institute-funded projects on biomarker validation under test-dependent sampling and pooled analysis of clinical trials data assembled from multiple sources on elderly lung cancer patients.