Richard C. Zink, PhD

About

Richard C. Zink is Vice President of Biostatistics and Statistical Programming at Lexitas Pharma Services where he leads in the design and analysis of ophthalmology clinical trials on behalf of their clients. Prior to Lexitas, Richard spent 17 years in and around medical product development at a real-world data company (Target RWE); a software company (SAS Institute); and pharmaceutical companies (Inspire Pharmaceuticals and Bristol-Myers Squibb). He is currently an Associate Editor for the DIA journal Therapeutic Innovation & Regulatory Science. He was the 2019 Chair of the Biopharmaceutical Section of the American Statistical Association, and former host of the Biopharmaceutical Section Statistics Podcast where he recorded 100 episodes over 10 years. Richard is author, editor, and contributor to 9 books on statistical topics in clinical trials and clinical research. He holds a Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill, where he serves as Adjunct Professor of Biostatistics. Richard was awarded the distinction of Fellow of the American Statistical Association in 2020.

Research Activities

-Real world data/evidence, analysis of safety endpoints, subgroup identification for patients with enhanced treatment response, and risk-based monitoring and fraud detection in clinical trials. 

Service Activities

-Associate Editor for the DIA journal Therapeutic Innovation & Regulatory Science

Key Publications

Biostatistical considerations when using RWD and RWE in clinical studies for regulatory purposes: A landscape assessment. Levenson M, He W, Chen J, Fang Y, Faries D, Goldstein BA, Ho M, Lee K, Mishra-Kalyani P, Rockhold F, Wang H & Zink RC.  (2023). Statistics in Biopharmaceutical Research.

Analysis considerations for real-world evidence and clinical trials related to safety. In Wang W, Buchanan J, Li J & Munsaka M, eds. Zink RC, Munsaka M, Emir B, Ma Y, Li J, Wang W & Bennett D.  (2022). Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches.

Understanding the influence of individual variables contributing to multivariate outliers in assessments of data quality. Zink R. C., Castro-Schilo L., and Ding J. (2018). Pharmaceutical Statistics, 17.

Sources of safety data and statistical strategies for design and analysis: Clinical trials. Zink R.C., Marchenko O., Sanchez-Kam M., Ma H., and Jiang Q. (2018). Therapeutic Innovation & Regulatory Science, 52.

Advanced randomization-based methods in clinical trials. Zink R.C., Koch G.G., Chung Y., and Wiener L.E. (2017). Analysis of Clinical Trials Using SAS: A Practical Guide, Second Edition.

Education