Lisa Meier McShane

Lisa Meier McShane, Ph.D., is an Associate Director for the Division of Cancer Treatment and Diagnosis (DCTD), U.S. National Cancer Institute, National Institutes of Health. She heads the Biometric Research Program (BRP), comprising statisticians, bioinformaticians, and computational biologists in Biostatistics and Computational and Systems Biology Branches. She is an internationally recognized expert on development of tumor markers for prognosis, therapy selection, and disease monitoring; omics-based predictors for clinical use; and reporting guidelines for health research studies. Dr. McShane holds a Ph.D. in Statistics from Cornell University and is a Fellow of the American Statistical Association. Her statistical research interests include biomarker-driven clinical trial design, analysis of high-dimensional omics data, multiple comparisons methods, surrogate endpoints, and biomarker assay analytical performance assessment. She co-led efforts to develop “Reporting guidelines for tumor marker prognostic studies (REMARK)” and “Criteria for the use of omics-based predictors in clinical trials.” She has coauthored numerous statistical and biomedical papers and the book Statistical Design and Analysis of DNA Microarray Investigations.

Dr. McShane serves on the Scientific Advisory Board for Science Translational Medicine and Editorial Board for BMC Medicine. She has served on American Society of Clinical Oncology committees that developed guidelines for HER2 and hormone receptor testing in breast cancer, EGFR mutation testing in lung cancer, and biomarkers in early stage breast cancer. She has served as a member of the Institute of Medicine Committee for Management of the Air Force Health Study Data and Specimens, the Consensus Committee on Management of the Air Force Health Study Data and Specimens-Report to Congress, and the Committee on the State of the Science in Ovarian Cancer Research.