Lead SAS/CDISC Programming Manager - Onsite NYC

Axsome Therapeutics, Inc.; New York (NY); On-site; USD 130,000 - 155,000; Full time

Benefits offered by this job

Annual Bonus

Equity

Generous Benefits

Job summary

Axsome Therapeutics, based in New York City, seeks a Manager/Senior Manager of Statistical Programming to lead programming across multiple CNS trials. You will develop SDTM/ADaM datasets and TFLs, coordinate with Biostatistics, and manage CROs for regulatory submissions.

The role demands on-site presence three days per week and a strong track record in CDISC standards and eSubmission packages. Salary ranges from $130,000 to $155,000 with bonus and equity.

Qualifications

• Bachelor-level degree in a relevant field.
• 5+ years SAS programming/data analysis in pharma/CRO (Manager) or 8+ years (Sr Manager).
• Subject matter expertise in CDISC standards; SDTM/ADaM lead experience.
• Experience developing eSubmission data packages for regulatory submissions.

Responsibilities

• Lead study programmer on one or more clinical trials.
• Collaborate with Biostatistics and Data Management to ensure accuracy of results.
• Develop, validate, and execute SAS programs for SDTM/ADaM datasets and TFL outputs.
• Manage CRO partners to deliver datasets and TFLs on schedule.
• Contribute to SAP, TFL specs, CRO plans, and regulatory documents.
• Lead eSubmission data package planning and quality checks (SDRG, ADRG, define.xml, SDSP).
• Provide hands-on programming and rapid responses to FDA inquiries.

Skills

SAS programming

SDTM/ADaM leadership

CDISC data standards

Regulatory submissions

Education

Bachelor's degree in Computer Science, Mathematics, Statistics, Engineering, Life Science, or related discipline

Tools

SAS

Job description

Axsome Therapeutics, based in New York City, seeks a Manager/Senior Manager of Statistical Programming to lead programming across multiple CNS trials. You will develop SDTM/ADaM datasets and TFLs, coordinate with Biostatistics, and manage CROs for regulatory submissions.

The role demands on-site presence three days per week and a strong track record in CDISC standards and eSubmission packages. Salary ranges from $130,000 to $155,000 with bonus and equity.