Office of Biostatistics Cytel Software

The Office of Biostatistics requires Cytel software to support critical review functions involving power and sample size calculations, adaptive clinical trial designs using EAST, and exact statistical analyses via StatXact. The contract is driven by the need for specialized statistical tools that enable accurate and compliant regulatory evaluations, particularly those requiring precise methodologies not fully supported by standard software. Increased costs are attributed to upgrades and additional licensing for StatXact procedures linked to SARGE in SAS environments, reflecting expanded usage and enhanced computational demands. The procurement is forecasted by the Food and Drug Administration under NAICS code 519130, with no set-aside designation, and will be managed through the Center for Drug Evaluation and Research acquisitions office, with inquiries directed to the Cder Acquisition Liaison. The contracting officer position remains to be determined at this stage.