Senior Statistical Programmer (contract)

COMPASS PathwaysNew York City, NY
72d

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. This position is a fixed-term contract for 9 months, located on the East Coast, USA, or hybrid in our NYC Office. The role reports to the Associate Director, Statistics and Data Management.

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

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What This Job Offers

Career Level

Senior

Industry

Professional, Scientific, and Technical Services

Number of Employees

101-250 employees

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