Job Description

About the Role
Title:
Senior Statistical Programmer (contract)
Location:
New York City United States or East Coast
Job Description:
Job overview:
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.
Location: Hybrid in our NYC Office or remote in the East Coast.
Reports to: Associate Director, Statistics and Data Management.
Duration: 9-month contract.
Roles and Responsibilities
(Include but are not limited to):
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
Candidate Profile:
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