Rob Woolson

Chief Strategist, Biostatistics & Standards for Regulatory Submissions

Rob Woolson

Rob Woolson

Chief Strategist, Biostatistics & Standards for Regulatory Submissions

Joining the team in 2007, Rob Woolson brings 20 years of experience as an applied statistician to his current role as Rho’s Chief Strategist for Regulatory Biostatistics and Data Standards.

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).

He supports regulatory agency interactions in the ADHD setting, including representing sponsors on multiple occasions at FDA DPP meetings and teleconferences, as well as authoring numerous responses to FDA queries.

Mr. Woolson’s educational background includes a Bachelor’s degree in mathematics from Northwestern University, a Juris Doctor degree from DePaul University, and a Master’s degree in applied statistics from DePaul University.

This is what drives Rob:

“Moving a product from early development through a regulatory marketing application rarely progresses in a straight line, and helping sponsors overcome regulatory, analytical, and other challenges is very rewarding to me. However, the impact that our work has on patients’ lives really makes the work we do worth it. On more than one occasion, I have been supporting a sponsor through an FDA Advisory Committee and have been struck by the public patient testimonials during these meetings. These testimonials remind me how much what we do really matters to public health and to individual patients.

And I have been fortunate to have been a part of numerous successful and impactful development programs throughout my career. Many of my engagements with sponsors have lasted years, through numerous studies and phases of development. Those phone calls I’ve received from sponsors on the day a product approval letter arrived have been some of the most rewarding days of my career. Knowing that I contributed, in some way, to bringing a safe and effective therapy to patients … that’s all the drive I need.”