Understanding how to Build and Leverage a DSMB Statistical Plan

The DSMB's statistical center is critical in ensuring the DSMB has accurate data to monitor participant safety, providing:

• DSMB statistical analysis plans (SAPs)
• SAS-derived dataset programs
• Tables, listings, and graphs (TLG) programming
• SAS programming validation per 21 CFR Part 11
• Periodic statistical reports for the DSMB per SAP
• Unblinded statistician(s) for the DSMB

Find out about the DSMB statistician’s roles, how study design can impact DSMB analysis, and what goes into a DSMB statistical plan.

Download the white paper.