South San Francisco, CA30+ days ago
Act as the primary study contact and provide oversight for all biostatistics related activities outsourced to CROs and external vendors Work closely with colleagues (Medical, Data Management, Statistical Programmers, Medical Writing, Safety, Clinical Operations, and Regulatory teams) to: Review protocols and prepare statistical methods section(s), including sample size estimation and clinical endpoint selection, to ensure Structure's conducts well designed, efficient, and cost-effective as well as statistically valid clinical trials Generate and/or review randomization schedule(s) to ensure high statistical quality of clinical protocols and analyses. Provides biostatistics support to Structure's expanding portfolios Provide statistical support for clinical study design, endpoint selection, sample size calculations, randomization schedules, statistical analysis plans (SAP) and data interpretation in collaboration with all team members, including programmers, data manager, medical writers and clinicians.