Statistical Programmer- II - Katalyst Healthcares and Life Sciences : Job Details

Statistical Programmer- II

Katalyst Healthcares and Life Sciences

Job Location : New York,NY, USA

Posted on : 2025-08-05T07:50:42Z

Job Description :
Responsibilities:
  • Develop, test, and validate SAS programs to generate analysis datasets (ADaM), TLFs, and ad-hoc reports.
  • Ensure datasets and outputs adhere to CDISC standards and regulatory guidelines (e.g., FDA, EMA).
  • Collaborate with Biostatisticians, Data Management, and Clinical Teams to define specifications and resolve data issues.
  • Review and interpret statistical analysis plans (SAPs) and provide programming support accordingly.
  • Participate in quality control (QC) and peer review of programs, outputs, and documentation.
  • Maintain accurate and audit-ready documentation, including programming logs, annotation, and specifications.
  • Support integrated summaries of efficacy (Client) and safety (ISS) for regulatory submissions.
  • Assist in mentoring junior programmers as needed.
Requirements:
  • Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
  • 5+ years of SAS programming experience in a pharmaceutical, CRO, or biotech environment.
  • Strong experience with CDISC standards (SDTM, ADaM) and regulatory submission processes.
  • Hands-on experience with SAS/Base, SAS/Macro, SAS/SQL, SAS/STAT.
  • Familiarity with clinical trial data, CRFs, and data management processes.
  • Ability to manage multiple projects, meet deadlines, and work independently.
  • Excellent communication skills and attention to detail
  • Experience with eCTD submissions and FDA guidance
  • Exposure to R, Python, or other statistical tools is a plus
  • Knowledge of tools like Pinnacle 21, Review, or JMP
  • Experience in oncology, rare disease, or CNS.
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