- Home
- Remote Jobs
- Senior Statistical Programmer
Date Posted
Today
New!Remote Work Level
100% Remote
Location
Remote in New York City, NY, ME, NH, MA, RI, CT, NY, NJ, DE, MD, VA, NC, SC, GA, FL
Salary
We're sorry, the employer did not include salary information for this job.
Categories
Data Entry, Data Science, Clinical Research, Product Manager, Project Manager, Software Engineer
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