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Roseann White, who brings over two decades of diverse biostatistics experience to Syntactx, provides expert advice on the development of clinical trial designs and analyses for clients seeking regulatory approval and reimbursement.

Roseann’s vast knowledge encompasses projects for medical device, diagnostic products, and breakthrough technologies, and she excels at resolving statistically related issues that arise during the product approval process. Roseann brings credibility to the table, having had leadership roles with Chiron, Guidant, and Abbott Vascular in biostatistics, data management, and health economics, outcomes research and reimbursement (HEOR). She later served as the Director of Pragmatic Clinical Trials at Duke Clinical Research Institute during which she successfully represented companies at meetings with regulatory authorities, including with the U.S. FDA, Japan Pharmaceutical and Medical Devices Agency (PMDA), the European Medicines Agency (EMA) competent authorities, and the Chinese cFDA.

Roseann completed her undergraduate studies with a concentration in cellular and molecular biology at the University of Michigan, Ann Arbor and has a Master of Arts degree in Statistics from the University of California, Berkeley. She also serves as a volunteer statistician with MDEpiNet, a public-private collaboration focused on the inclusion of global real-world evidence collaborative for health technologies.