Associate Statistical Programming Director

Role: Lead statistical programming activities for clinical studies, ensuring data analysis, QC, and standardization in line with regulatory standards. Responsibilities: develop and maintain macros, datasets (SDTM, ADaM), and analysis programs using SAS and R; oversee CRO deliverables; support data integration and regulatory submissions; provide training and guidance on macro use; coordinate data transfers and study timelines; ensure compliance with FDA and CDISC standards. Qualifications: BS/BA with 11+ years, MS/MA with 9+ years, or PhD with 5+ years of experience in pharma/biotech programming; expert in SAS/Base, SAS/Stat, SAS/Macros, R, UNIX, with knowledge of CDISC standards. Preferred: oncology trial experience, NDA submission familiarity, UNIX, and SAS graphics. High-value: senior-level role with extensive industry experience, leadership in data programming, and involvement in regulatory filings; emphasis on data standards, quality control, and cross-functional collaboration. Work setup details are not specified.