Manager, Statistical Programming

Role: Manager of Statistical Programming leading a team in early-phase pharmaceutical research and development, focusing on specific compounds, indications, or therapeutic areas. Objectives include ensuring timely, quality deliverables of SAS-based data sets and reports aligned with regulatory standards. Responsibilities encompass managing programming activities, team resource planning, developing SAS programs for ADaM data sets and TLFs, and creating documentation for submissions. The role requires overseeing standard macros and SOPs, and mentoring staff. Qualifications: MS in Statistics, Computer Science, or related with 8+ years, or BS with 10+ years of relevant experience; proven leadership of statistical programming teams; deep SAS expertise, knowledge of CDISC standards, and understanding of drug development and regulatory filings. Preferred: experience with cross-functional collaborations and process improvements. High-value specifics include expertise in early development (preclinical/indication-specific), regulatory documentation, GxP compliance, and cross-team interfaces in statistics, data sciences, medical writing, and clinical operations. Location is flexible with potential remote or hybrid work; travel not specified.