Manager/Senior Manager, Statistical Programming

Role: Manager/Senior Manager, Statistical Programming supporting clinical development of neurology compounds at Axsome Therapeutics. Primary responsibilities include leading programming efforts for multiple trials, ensuring accurate data analysis, and preparing datasets and reports for regulatory submissions. The role involves managing CRO partnerships, developing and validating SAS programs for SDTM and ADaM datasets, and contributing to eSubmission package planning and quality checks. It requires hands-on programming, ad hoc analyses, and rapid regulatory responses. Responsibilities also include contributing to SOPs, knowledge transfer, and staying current with programming advances. Requirements: Bachelor's in relevant field; 5+ years (Manager) or 8+ years (Senior Manager) SAS programming experience in pharma/biotech or CRO; expertise in CDISC standards, SDTM, and ADaM; experience with regulatory data packages. Preferred skills: SAS certification, R/Python skills, strong communication, and ability to manage CRO activities. The position is based in New York City with onsite presence at least three days per week; remote work is not considered. The role offers a salary range of $130,000-$155,000, with a comprehensive benefits package.