Job Description

Job Description:
The 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.

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.

Requirements:

• Bachelor's/master's degree in a Scientific Discipline.
• 6+ 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/Client 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.
• bility to solve challenging problems and provide recommendations to mitigate risk.
• Good communication skills - both written and verbal.
• Team works skills - Including cross-functional and within the Statistics and Data Management Team.

Job Tags

Interim role

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