John Hinkle, Ph.D., is President, CEO, and Chief Statistician of EarlyPhase Sciences, which he founded in 2010. EarlyPhase is a senior biometrics team of statisticians, programmers, and data managers supporting pharmaceutical, biotechnology, and life sciences companies with study design, analysis, and submission-ready deliverables—particularly when timelines are tight and the data must withstand regulatory scrutiny.

Before founding EarlyPhase, Dr. Hinkle was the lead statistician for the NDA and MAA for emtricitabine (FTC; Emtriva, Truvada) at Triangle Pharmaceuticals. Following Gilead Sciences' acquisition of Triangle, he remained with Gilead in progressively senior roles as Manager, Associate Director, and Director of Biostatistics in Durham, North Carolina. FTC was approved in 2003 and remains a backbone of widely used HIV regimens, including Biktarvy and Descovy.

His work at Triangle and Gilead spanned Phase I–III antiviral development, including first-in-human, drug-interaction, bioequivalence, non-inferiority, and superiority studies. He is an author of the 2004 JAMA trial comparing FTC with stavudine, as well as related publications in HIV clinical research. His full publication record is available on Google Scholar.

Earlier in his career, Dr. Hinkle consulted through INI Research, supporting programs including raloxifene for osteoporosis with Eli Lilly and Atacand with AstraZeneca. He holds a Ph.D. in Statistics (1995) and an M.S. in Statistics (1993) from the University of Kentucky and a B.S. in Mathematics (1991) from the University of North Carolina at Chapel Hill.

At EarlyPhase, Dr. Hinkle remains a working statistician. He helps shape study strategy and statistical design and analyses, assembles senior teams for each engagement, and stays closely involved through analysis and delivery to ensure the work is accurate, timely, and ready for its intended scientific or regulatory use.