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Statistical Programmer
Statistical ProgrammerKatalyst HealthCares & Life Sciences • Rochester, NY
Statistical Programmer

Statistical Programmer

Katalyst HealthCares & Life Sciences • Rochester, NY
[job_card.30_days_ago]
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  • [job_card.temporary]
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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 :

  • 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.
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