Biostatistician for DSMB

Job Summary

Seeking an experienced Biostatistician for DSMB on a remote contract basis, this role involves reviewing interim analysis reports and providing recommendations on study continuation for an FDA-regulated clinical study evaluating a mobile health application.

Key responsibilities

• Evaluate periodic interim analysis reports for safety, efficacy, and data quality, translating statistical findings into actionable conclusions
• Assess study progress against FDA-recommended stopping boundaries and safety thresholds to ensure regulatory alignment
• Participate in closed DSMB sessions to discuss findings and contribute to official recommendations regarding study continuation or termination

Required qualifications

• Ph.D. or Master's degree in Biostatistics, Statistics, or a closely related field
• Prior experience serving on a DSMB or Data Monitoring Committee for FDA-regulated studies
• Strong knowledge of sequential interim analyses, group sequential designs, and stopping rule boundaries
• Familiarity with Software as a Medical Device (SaMD) or mobile health applications is highly desirable
• Ability to maintain strict confidentiality regarding unblinded interim data and board discussions