Manager/Senior Manager, Statistical Programming

Axsome Therapeutics is a biopharmaceutical company seeking a Manager/Senior Manager, Statistical Programming to provide programming support for multiple neurology compounds across all phases of development. The role will serve as lead programmer on assigned clinical trials, working closely with Biostatistics and Data Management. The Senior Manager, Statistical Programming will apply programming methodology to summary and analysis of clinical trial data, developing and utilizing SAS programs and macros to create and validate CDISC Study Data Tabulation Model (SDTM) conformed datasets, Analysis Dataset Model (ADaM) datasets, and Tables, Figures, and Listings (TFLs) as scoped in the Statistical Analysis Plan (SAP) for reporting purposes in the Clinical Study Report (CSR).

Requirements

• Bachelor’s degree (BA or BS) in Computer Science, Mathematics, Statistics, Engineering, Life Science, or related discipline
• 5+ years of SAS programming and/or data analysis experience gained within the pharmaceutical or biotechnology industry, or at a Contract Research Organization (CRO) for Manager level
• 8+ years of SAS programming and/or data analysis experience gained within the pharmaceutical or biotechnology industry, or at a Contract Research Organization (CRO) for Senior Manager level
• Subject matter expertise on CDISC data standards and proven experience working with CDISC-compliant data
• 2+ years of SDTM and ADaM lead experience
• Demonstrated experience developing and validating eSubmission data package components for regulatory submissions, amendments, and supplements
• Ability to work on-site Monday, Tuesday & Thursday
• SAS Certification is highly preferred; R or Python programming skills are desirable

Benefits

• Annual bonus
• Significant equity
• Generous benefits package