Navigating Regulatory Biostatistical Requirements | Page 15

AUTHOR BIOS Ron Marks, PhD Chief Scientific Officer, Director of Biostatistics, Co-Founder, Clinipace Worldwide Ron is a skilled, knowledgeable biostatistician and biomedical researcher, having served on the University of Florida faculty for 30 years in the Division of Biostatistics. In 2004, he retired from the university, and he now devotes his time fully to building Clinipace Worldwide and assisting in product design, trial execution, and customer support. He has an extensive background in design, analysis, and reporting of large-scale clinical trials and other research studies and has been a lead clinical trial consultant with a number of large pharmaceutical companies, including Unilever, Braun, Procter & Gamble, and GSK. Scott Miller, PhD Biostatistician, Clinipace Worldwide As a biostatistician with Clinipace, Scott works on trials ranging from Phase 1 to 4, providing statistical input into clinical trial protocols and eCRFs, writing statistical analysis plans and TFL shells, implementing statistical analyses, and interacting with the FDA in protocol submission meetings or response letters. Prior to working at Clinipace, he spent five years at the FDA’s Center for Devices and Radiological Health, first as a statistical reviewer and then as a team leader. He was responsible for reviewing trial protocols for IDEs as well as pre-market clearance (510k) and approval (PMA) submissions for medical devices – primarily those with orthopedic and neurologic indications. 15