Ben Vaughn

Chief Strategist, Biostatistics & Protocol Design

Ben Vaughn

Chief Strategist, Biostatistics & Protocol Design

A proven leader in the industry for more than 20 years, Mr. Ben Vaughn serves as Rho’s Chief Strategist for Biostatistics and Protocol Design. In this role, he utilizes his extensive expertise to guide sponsors through marketing applications, regulatory interactions, and the design and analysis of analgesia trials.

Mr. Vaughn has supported over 75 pain trials, over 30 marketing applications, and 6 FDA advisory committee meetings (both back room and bullpen) over the course of his career and has had speaking roles in dozens of FDA Type A, B, and C meetings.

His experience spans many therapeutic areas with emphasis on abuse liability trials, substance use disorders, as well as other psychiatric disorders and rare disease (orphan) products.

Mr. Vaughn earned both his bachelor’s and master’s degrees in Biostatistics from UNC-Chapel Hill.

Why Neurology and Analgesia?

“Neurology, and specifically pain-related clinical trials, is a fascinating area of research for me due to the obstacles that are presented. The outcomes are highly subjective and prone to influence by a number of factors completely unrelated to the investigational product being tested. Missing data cannot be ignored and novel analysis approaches are needed to evaluate their influence on trial outcomes. Addressing these concerns to the agency’s satisfaction is challenging but rewarding work.”

This is what drives Ben:

“Opioids have a place in the treatment of pain, but our understanding of their roles and risks has shifted over the course of my career. I am passionate about both ensuring their appropriate availability to patients that require them and finding products that can replace opioids. In the meantime, I am an ardent supporter of research to better understand treatment of substance use disorders and the role of prescription opioids in leading to such disorders, as well as the promotion of wide availability of medication assisted therapy and naloxone.”


Content by Ben Vaughn