James M. Robinson

Mr. Robinson is vice president, biostatistics and data sciences at Autobahn Therapeutics. Mr. Robinson is a seasoned pharmaceutical biometrics leader with over 27 years of experience in biostatistics, data sciences, and clinical development, having held senior leadership positions at companies such as Oncternal Therapeutics, Otonomy, Conatus Pharmaceuticals, and Dexcom, overseeing global biometrics strategies.

Mr. Robinson is recognized for his ability to align biometrics functions with corporate objectives, collaborating closely with executive leadership to drive product lifecycle planning, regulatory submissions, and innovative trial designs. His regulatory expertise spans NDAs, BLAs, PMAs, 510(k)s, and advisory committee preparations, contributing to numerous successful submissions including products such as DIFICID, Aranesp, Once-A-Week Prozac, and several medical devices for obesity, diabetes, and sleep apnea.

In addition to leading internal teams, Mr. Robinson has extensive experience managing CRO partnerships, safety review committees, and cross-functional data strategies. He has provided strategic and operational oversight for biostatistics, programming, and clinical data management departments, and supported global regulatory interactions, including INDs and DSURs.

Mr. Robinson holds an M.S. in applied statistics from Purdue University Indianapolis and a B.S. in mathematics (statistics concentration) from Sonoma State University, where he graduated with distinction. He has also contributed to professional education as an instructor at UCSD Extension, where he co-developed a certification program in clinical biostatistics.