Rob Woolson

Joining the team in 2007, Rob Woolson brings 20 years of experience as an applied statistician to his current role as Rho’s Vice President of Regulatory Strategy & Biometrics.

Mr. Woolson has an extensive background working with small biotech and pharmaceutical companies to successfully bridge and navigate the biometrics, CDISC data standards, and regulatory requirements of drug and biologics development. He has advised and supported sponsor companies through 12 marketing applications in several therapeutic areas, including playing a vital role in numerous FDA and Advisory Committee meetings.

Much of Mr. Woolson’s work has focused on psychiatry-related product development, with an emphasis on therapies related to pediatric and adult ADHD. He has led the study design, analytical planning, regulatory data standards compliance, and ISS and ISE analysis design and execution in numerous pediatric and adult ADHD development programs, including 4 products approved by the Division of Psychiatry Products (DPP).