Principle Statistical Programmer - Katalyst CRO : Job Details

Principle Statistical Programmer

Katalyst CRO

Job Location : New York,NY, USA

Posted on : 2025-04-30T11:23:07Z

Job Description :

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Responsibilities
  • Provide quality deliverables by following corporate and departmental policies, procedures, and applicable standards.
  • Perform data manipulation, analysis, and reporting of clinical trial data.
  • Create analysis files, tables, listings, and figures, and validate those files.
  • Maintain project tracking and validation documentation.
  • Work effectively in a distributed team environment.
  • Ensure project objectives are met with clarity, accuracy, and completeness of programming requirements.
  • Present statistical programming concepts to non-programming team members as necessary.
  • Collaborate with cross-functional teams and interface with stakeholders to manage timelines and priorities.
  • Serve as back-up to the Principal Statistical Programmer as needed.
  • Requirements
  • 7-10+ years of statistical programming experience in the pharmaceutical/CRO industry.
  • Strong macro development experience is required.
  • PK/PD programming experience is a plus.
  • Bachelor's or Master's in Statistics, Mathematics, Computer Science, Life Sciences, or related fields with 7-8+ years of relevant experience.
  • Extensive regulatory submission and response experience.
  • Proficiency in SAS programming with excellent analysis and reporting skills.
  • Knowledge of drug development lifecycle and clinical trial data analysis/reporting.
  • Thorough knowledge of CDISC SDTM, ADaM, and Define standards.
  • Ability to oversee geographically diverse programming teams.
  • Project management experience in drug development projects.
  • Knowledge of SAS Graph and statistical packages.
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