Associate Director, Statistical Programming

Role: Associate Director, Statistical Programming, leading programming activities for clinical trials in a biopharma focused on autoimmune diseases. Primary objectives include supporting clinical studies, study reports, and regulatory submissions, while contributing to departmental process improvements and tool development. Responsibilities: act as the main programming contact for protocols and analyses, oversee programming deliverables from internal teams and vendors, collaborate across functions (Biostatistics, Data Management, Clinical Operations), review specifications and datasets, perform QC, program analyses for regulatory and scientific purposes, and mentor junior staff. Qualifications: Master’s in Biostatistics, Computer Science, or related field with 7+ years (or Bachelor’s +9+ years) experience across all trial phases; experience managing CROs/vendors; expertise in regulatory filings, SDTM/ADaM standards, and familiarity with ICH, FDA, EMA guidelines; strong SAS skills, with R preferred; excellent communication and problem-solving abilities; adaptable to fast-paced, global environment with non-traditional hours. High-Value: experience supporting regulatory submissions (NDA/BLA), working with cross-functional teams, and managing external programming resources. Worksetup: not specified, but likely hybrid or remote given global scope.