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