Manager/Senior Manager, Statistical Programming

Responsibilities

• Serve as lead study programmer on one or more clinical trials
• Work in collaboration with Biostatistics and Data Management to ensure the accuracy and reliability of reported results
• Develop, validate, and execute SAS programs and macros to generate SDTM and ADaM datasets and TFL outputs
• Manage CRO partners to ensure delivery of datasets and TFL outputs according to project timelines
• Lead eSubmission data package planning, execution, and quality checks of eCRT package components
• Provide hands-on programming for ad hoc analyses and rapid response to regulatory inquiries
• Contribute to the development of Standard Operating Procedures (SOPs) and templates

Requirements

• Bachelor’s degree in Computer Science, Mathematics, Statistics, Engineering, Life Science, or related discipline
• 5+ years of SAS programming experience (Manager level) or 8+ years (Senior Manager level) in pharma, biotech, or CRO
• Subject matter expertise in CDISC data standards
• 2+ years of SDTM and ADaM lead experience
• Experience developing and validating eSubmission data package components
• Ability to work on-site in New York City (Monday, Tuesday, and Thursday)

Preferred Qualifications

• SAS Certification
• R or Python programming skills

About the Company

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions, focusing on novel mechanisms of action to improve patient outcomes in neuroscience.