Manager/Senior Manager, Statistical Programming

Scorpion Therapeutics; United States; On-site; USD 130,000 - 155,000; Full time

Benefits offered by this job

Comprehensive benefits package

Onsite in NYC (3 days/week)

Job summary

Axsome Therapeutics is seeking a Manager/Senior Manager of Statistical Programming to support clinical development of neurology compounds. You will lead programming for multiple trials, prepare SDTM/ADaM datasets and regulatory submission packages, and manage CRO partnerships.

Hands-on coding, ad hoc analyses, and rapid regulatory responses are required. The role requires a Bachelor's degree and 5+ to 8+ years of SAS experience in pharma/CRO, with CDISC SDTM/ADaM expertise and regulatory data

Qualifications

• Bachelor's degree in a relevant field.
• 5+ years (Manager) or 8+ years (Senior Manager) of SAS programming in pharma/biotech or CRO.
• Expertise in CDISC standards, SDTM, and ADaM.
• Experience with regulatory data packages.

Responsibilities

• Lead programming for multiple trials and ensure accurate data analyses.
• Prepare datasets and regulatory submission reports (eSubmission readiness).
• Manage CRO partnerships and CRO activities related to programming.
• Develop and validate SAS programs for SDTM/ADaM datasets and QA processes.
• Contribute to SOPs, knowledge transfer, and keep up with programming advances.

Skills

SAS programming

Regulatory data analysis

Project leadership

Education

Bachelor's degree in a relevant field

Tools

SAS

Job description

Role

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

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

Preferred skills: SAS certification, R/Python skills, strong communication, and ability to manage CRO activities.

Location

The position is based in New York City with onsite presence at least three days per week; remote work is not considered.

Compensation & Benefits

The role offers a salary range of $130,000-$155,000, with a comprehensive benefits package.