Senior Statistical Programmer (contract)

Compass Pathways • New York, NY

11h • Hybrid

About The Position

The Senior Statistical Programmer will contribute expert programming skills to deliver accurate, regulatory-compliant clinical data outputs for Compass Pathways development programs. The role requires strong technical proficiency, collaboration across teams, and adaptability to support complex clinical trial requirements.

Requirements

• Extensive years experience in statistical programming
• CDISC expertise
• Proficient in programming including performing statistical analyses and creating macros in SAS, preferably R
• Programming/reporting expertise across all phases of clinical development (efficacy/safety/PK), including ISS/ISE reporting
• Experience in performing quality control (QC) checks
• Extensive knowledge in regulatory submission process
• Good understanding of ICH guidelines and regulations such as 21 CFR Part 11
• Experience supporting NDA submissions e.g., FDA, EMA, MHRA and addressing regulatory questions
• Ability to solve challenging problems and provide recommendations to mitigate risk
• Good communication skills - both written and verbal
• Team work skills - Including cross-functional and within the Statistics and Data Management Team

Responsibilities

• Leading and coordinating the programming activities within agreed timelines
• Managing the reporting of studies internally and externally
• Programming outputs as stated in the analysis plan
• Working closely with study team members, mainly with the study statistician
• Reviewing of the Statistical Analysis Plan (SAP) and shells
• Create and review SDTM and ADaM study specifications
• Ensure programs, datasets, outputs are appropriate for regulatory submission
• Perform simulations and data modelling
• Perform Interim analyses
• Liaise with external vendors on deliverables

What This Job Offers

• Career Level: Mid Level
• Education Level: No Education Listed