Richard C. Zink, PhD

About

Richard C. Zink (he/him) is Principal Research Fellow at JMP Statistical Discovery, LLC where he identifies, researches, and overcomes obstacles in the medical product and life science industries. He has spent 20+ years contributing statistical thinking and analytical prowess in and around medical product development to address unmet medical need, streamline the interpretation and communication of data, accelerate the review of patient safety, and enhance data quality. Richard is Associate Editor for the DIA journal Therapeutic Innovation & Regulatory Science where he has served for more than 10 years. 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 a 10-year period. Richard is author, editor, and contributor to 9 books on statistical topics in clinical trials and clinical research. He holds a PhD 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

• Data visualization
• Analysis of Safety Endpoints
• Statistical Leadership

Service Activities

• Leadership-in-Practice (LiPCom) Committee, Biopharmaceutical Section, American Statistical Association
• Associate Editor for the DIA journal Therapeutic Innovation & Regulatory Science

Key Publications

Aggregate IND safety reporting for smaller companies and programs. Ball G, Li M, Buchanan J, Hendrickson B, Zink RC, Snapinn S & Herson J. (2024). Therapeutic Innovation & Regulatory Science.

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