Compass Pathways

About the Company

We are Compass Pathways, a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our first clinical development programme is researching investigational COMP360 psilocybin treatment for patients with treatment-resistant depression. We want to transform the patient experience in mental health care.

Listed Jobs

Company Name

Compass Pathways

Job Title

Senior Statistical Programmer (contract)

Job Description

Job Title: Senior Statistical Programmer (contract) Role Summary: Contribute expert programming skills to deliver accurate, regulatory-compliant clinical data outputs for clinical development programs. Collaborate cross-functionally to support complex trial requirements. Expactations: Strong technical proficiency, collaboration, adaptability, leadership in programming activities, and compliance with regulatory standards. Key Responsibilities: - Lead coordination of programming activities to meet timelines and study goals. - Manage internal and external study reporting, including ISS/ISE. - Develop datasets, programs, and outputs per analysis plans and regulatory specifications. - Collaborate with statisticians and cross-functional teams to review SAPs and SDTM/ADaM specifications. - Ensure compliance of datasets/outputs for global regulatory submissions (e.g., FDA, EMA). - Perform simulations, interim analyses, and quality control checks. - Liaise with external vendors to ensure timely deliverables. Required Skills: - Extensive statistical programming experience in clinical trials (all phases: efficacy/safety/PK). - CDISC (SDTM/ADaM) and regulatory submission expertise (ICH guidelines, 21 CFR Part 11). - Advanced proficiency in SAS; preferred R, Python, or other statistical software for analytics. - NDA submission experience (FDA, EMA, MHRA) and addressing regulatory queries. - Strong problem-solving, risk mitigation, and ability to deliver high-quality outputs under deadlines. - Excellent communication and teamwork across functions. Required Education & Certifications: Bachelor’s degree in statistics, mathematics, or life sciences; Master’s preferred. Certifications in statistical programming (e.g., SAS, CDISC) or regulatory compliance desirable.

Palm coast, United states

Hybrid

Senior

11-10-2025