Statistical Programmer

Statistical Programmer

Statistical Programmer – Katalyst CRO

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.

• 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 the Statistical Analysis Plan (SAP) and shells.
• Creating and reviewing SDTM and ADaM study specifications.
• Ensuring programs, datasets, outputs are appropriate for regulatory submission.
• Performing simulations and data modelling.
• Performing interim analyses.
• Liaising with external vendors on deliverables.

• Bachelor's or master’s degree in a scientific discipline.
• 6+ years’ experience in statistical programming.
• CDISC expertise.
• Proficient in performing statistical analyses and creating macros in SAS, preferably with 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 of the 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.
• Teamwork skills—cross‑functional and within the Statistics and Data Management Team.

• Mid‑Senior level

• Contract

• Information Technology
• Pharmaceutical Manufacturing

Location:

Rochester, New York Metropolitan Area
Salary: $44,419 – $62,186