Jennifer Nezzer is the Sr. Director of Biostatistics at Advance Research Associates (ARA), located in Santa Clara, California. Home based in Austin, TX, as the head of the biostatistics and programming departments, she is responsible for the recruitment and management of team members, for providing technical leadership on the all aspects of numerous development projects in North America as well as providing consulting services to clients and serving as lead statistician on global programs. Prior to joining ARA, she was Director of Biometrics at Lotus Clinical Research, where she established the Biostatistics department, managed the Biostatistics and Data Management departments, leading the teams during the early adoption of the Veeva EDC platform. Prior to that. Jennifer was a member of the biostatistics leadership team at Premier Research and supported the biostatistical development of numerous global programs at Premier and PPD for more than 10 years.
Jennifer has supervised the statistical aspects of Phase I through IV clinical trials from design through analysis and reporting for both traditional and adaptive study designs in a broad range of therapeutic areas including analgesia, oncology, endocrine/metabolic, infectious/parasitic diseases, CNS, genitourinary, hematology, diseases of the musculoskeletal system and connective tissue, congenital anomalies and mental disorders. She has participated in multiple NDA submissions to FDA including developing ISS/ISE and eCTD submission ready documents.
Jennifer has represented biostatistics in interactions with sponsor companies, in multiple NDA submissions and represented multiple sponsors in both phone and face to face interactions with both US and exUS regulatory agencies.
Prior to her tenure in the pharmaceutical industry, Jennifer served as a senior biostatistician for Signature Science, LLC for eight years providing statistical support for various quality assurance, field testing and environmental projects. She earned her BA in statistics from Kansas State University, and her MS in statistics from New Mexico State University. She is a member of the American Statistical Association, Phi Beta Kappa and Phi Kappa Phi.