Kenneth J. Wilkins, Ph.D.

Responsibilities & Activities

I am a mathematical statistician serving in the Biostatistics Program at the NIDDK, which provides advice to both extramural and intramural staff on the design, analysis, and feasibility of proposed research studies, and supporting the effective conduct of ongoing studies. Having taught courses at Harvard School of Public Health and Uniformed Services University of the Health Sciences, I add to the biostatistics program’s capacity for developing educational curricula and conducting training seminars; these efforts complement how the multidisciplinary Office of Clinical Research Support and Data Science and Data Management Working Group develop NIDDK-wide resources.

I also perform research on data-analytic methods, focusing on causal inference from longitudinal/multilevel or network-based studies and handling incomplete data, among other topics relevant to NIDDK research; I engage these same methodology communities to bridge the gap between methods innovation and implementation along two avenues. One seeks to better inform biomedical research practice via user-centered clearinghouses of methods application that leverage widely-available data, such as the NIDDK Central Repository and other NIH-sponsored platforms, emphasizing rich annotation by subject-matter experts and data contributors; the other seeks to share best practices in bridging the innovation-implementation gap across the statistical methodology and machine learning research communities. I actively contribute to related efforts supporting the NIH Strategic Plan for Data Science (PDF, 475 KB), from common data elements and entities to ontology-based knowledge graphs on such content, as a result. I myself consult and collaborate on research projects, whether developed within the extramural community (such as issues faced by research consortia, Data and Safety Monitoring Boards, or other government agencies) or by intramural investigators, contributing to the design, conduct, analysis, and dissemination of NIDDK-sponsored biomedical and clinical research.

I earned a Ph.D. in biostatistics from Harvard University after using my master's degree from the University of Virginia to teach gifted high school students at a regional magnet school. Prior to joining the NIDDK, I served as a senior biostatistician in data coordination center leadership for the Infectious Disease Clinical Research Program. My duties ranged from scientific review of proposed research to development and implementation of multicenter protocols, helping to develop its worldwide research network sponsored jointly by the National Institute of Allergy and Infectious Diseases and the Uniformed Services University within the Department of Defense. My collaborations with and training of network investigators was informed by leading statistical efforts for well over a dozen NIH-sponsored trials supported by the EMMES Corporation in Rockville, Maryland, ranging from first-in-human pandemic vaccines to rare-disease therapeutics.

Committees & Working Groups

• Clinical Studies Working Group, Member
• Data Science & Data Management Working Group, Member
• Epidemiology Group, Member
• Intramural Research Program Safety Monitoring Committees Roster, Member
• NIH-wide Common Data Elements Working Group convened by NIH Scientific Data Council, Co-Chair
• NIH-wide Common Data Elements Governance Committee, Co-Chair
• NIH-wide Common Data Elements Task Force, Member
• NIH-wide Delegation to the FDA/NIH/NIST Interagency Ontology Roundtable, Member
• NIH-wide Fast Health Care Interoperability Resources® (FHIR®) in Research Working Group, Member
• NIH-wide Social Determinants of Health Research Coordinating Committee, Member
• NIH-wide UNITE Initiative’s N Committee Resource & Support Workstream, Member
• NIH-wide Nutrition Research Coordinating Committee, Member
• NIH-wide Obesity Research Task Force, Member
• Diabetes Mellitus Interagency Coordinating Committee, Member
• Kidney Interagency Coordinating Committee, Member
• Urology Interagency Coordinating Committee, Member
• NIH-wide Generative AI and Federal-wide AI Communities of Practice, Member