Statistical ProgrammerKatalyst HealthCares & Life Sciences • Rochester, NY
Statistical Programmer
Katalyst HealthCares & Life Sciences • Rochester, NY
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.temporary]
[job_card.job_description]Bachelor's / master's degree in a Scientific Discipline. 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 CFR Part . Experience supporting NDA submissions , 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 works skills - Including cross-functional and within the Statistics and Data Management Team.
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 :
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