Lisa Meier McShane, Ph.D.

Biography

Lisa Meier McShane, Ph.D., is Associate Director, Division of Cancer Treatment and Diagnosis, National Cancer Institute, where she heads the Biometric Research Program.  She earned a Ph.D. in statistics from Cornell University and is a Fellow of the American Statistical Association.  

Dr. McShane serves as an Associate Director for DCTD where she leads the Biometric Research Program. She advises the DCTD on matters relating to cancer clinical trials, cancer diagnostic and imaging studies.  She engages in research and consulting related to development and evaluation of cancer biomarkers and assessment of analytical validity of biomarker assays.  Additionally, she reviews protocols for laboratory correlative science studies and serves on teams that develop and conduct precision medicine cancer clinical trials. Dr. McShane joined DCTD in June 1996. Prior to joining NCI, Dr. McShane was a staff fellow mathematical statistician in the National Institute of Neurological Disorders and Stroke, NIH.

Dr. McShane is an internationally recognized expert on precision medicine clinical trial design; development of tumor markers and omics predictors for prognosis, therapy selection, and disease monitoring; and reporting guidelines for health research studies. 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 published extensively in statistical and biomedical journals and coauthored the book Statistical Design and Analysis of DNA Microarray Investigations. She is a frequent invited speaker at national and international oncology and statistics meetings.  Dr. McShane has served on American Society of Clinical Oncology committees that developed guidelines for biomarker testing to guide therapy breast and lung cancer, and she has served on FDA Molecular and Clinical Genetics and Clinical Chemistry and Clinical Toxicology Panels and multiple Institute of Medicine committees.

Education

• Ph.D., Statistics, Cornell University, Ithaca, New York
• M.S., Statistics, Cornell University, Ithaca, NY
• M.S., Statistics, University of Kentucky, Lexington, Kentucky
• B.A., Mathematics, Millersville State College, Millersville, Pennsylvania