Bioinformatics Analysis & Data Science Support

The contract seeks bioinformatics analysis and data science support leveraging FDA data standards such as CDISC, SEND, and ADaM to ensure consistency and regulatory alignment in data processing and reporting. The work requires robust statistical modeling capabilities and seamless integration of analytical outputs into regulatory systems, all governed by compliance with HHS EPLC and NIST frameworks to maintain data integrity and security. The scope emphasizes adherence to federal guidelines for data structure, quality, and interoperability as mandated by the Department of Health and Human Services. The opportunity is structured as a subcontract under NAICS code 541620, issued by the FDA Office of Acquisition and Grant Services, with performance located in Silver Spring, Maryland, zip code 20993. Proposals must be submitted by August 22, 2026, at 5:00 PM, following a posting date of August 7, 2026. No set-aside designation is applicable, and while specific contact details are not provided, submissions are managed through the SAM.gov portal. This engagement supports critical regulatory functions by bridging advanced data science with federal compliance requirements in a highly structured operational environment.