Clinical & Biostatistical Analysis Services

This subcontract for Clinical and Biostatistical Analysis Services supports prime contractors on FDA CDRH clinical device trials. The selected provider will be responsible for performing data analysis and statistical validation, conducting biostatistical reviews of clinical trials, and documenting all findings in comprehensive scientific reports. Key deliverables include statistical analysis reports and clinical trial validation documents, requiring specialized expertise in statistics, biostatistics, and clinical laboratory testing. Managed by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, the work is performed in Silver Spring. Compliance requirements include the completion of ethics training and conflict of interest background checks. The opportunity is categorized under NAICS code 541620, with a response deadline set for November 17, 2026.