Director, Statistical Programming

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About this role

Director, Statistical Programming South San Francisco, CA The Opportunity Maze is looking for a Director of Statistical Progr ammi ng , who will help shap e the data foundation of our clinical development programs . In thi s role y ou'll collaborate closely with colleagues across Biostatistics, Clinical Data Management, Clinical Operations, and Regulatory Affairs, and oversee external vendors to keep our studies rigorous, high-quality, and ready for regulatory review . You'll report to the Vice President of Biometrics and lead the stra tegy and day-to-day execution of statistical programmi ng across multiple clinical studies . You r leadership will ensure we deliver reliable, efficient , and regulatory-c ompliant programming outputs that drive smarter decisions and ad vance our therapeutic programs. The Impact You'll Have - Define and implement statistical programming strategy , standards, and best practices across development programs . - Lead the design, development, validation , and maintenance of SAS macros, scripts, and applications supporting clinical data analysis, reporting, and regulatory deliverables (e.g., SDTM, ADaM datasets, TLFs) . - Ensure programming infrastructure is robust , scalable, and compliant with regulatory standards (e.g., FDA 21 CFR Part 11, GxP ), and supports reproducibility and audit readiness . - Drive automation and standardization of programming workflows to improve efficiency and consistency across studies . - Partner closely with Biostatistics, Clinical Data Management, Regulatory Affairs , and IT to define programming requirements, align on analysis/reporting deliverables, and ensure data integrity . - Represent the statistical programming function in cross-functional meetings and

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