People: Simulations Plus Inc (SLP.OQ)
17 Jul 2019
Dr. Lisa LaVange is Director of the Company. Dr. LaVange currently serves as Professor and Associate Chair of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill. At UNC, she directs the establishment of a new Master's in Public Health (MPH) program with a concentration in data science, and is planning a regulatory science curriculum focused on statistical methodologies in two areas: precision medicine and real-world evidence. In addition, she is currently Principal Investigator (PI) of the coordinating centers for two large and complex trial networks: the NICHD-sponsored Adolescent Medicine Trials in HIV/AIDS Interventions Network (ATN) and the NHLBI-sponsored Precision Medicine in Severe and Exacerbation-Prone Asthma Network (PreciSE). From 2011 to 2017, Dr. LaVange served as Director of the Office of Biostatistics in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). In this role, she directed 215 statistical reviewers, analysts, and support staff involved in the development and application of statistical methodology for drug regulation. She was responsible for statistical review of all investigational drugs, therapeutic biologics, biosimilar products, and generic drugs. She also chaired the Statistical Policy Council and was a member of CDER's Medical Policy Council, setting statistical policy and overseeing statistical guidance development and publication for the Center. Previously, she worked for six years at Quintiles, Inc. (now IQVIA), serving as Vice President of Biostatistics for her last three years. Quintiles is the largest pharmaceutical outsourcing services company in the U.S. In this role, she directed over 200 statisticians and programmers located in five offices across North America, supporting clinical trial operations, regulatory submissions, and post-marketing evaluations for a variety of large and small pharmaceutical and biotechnology companies.
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