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Clinical Statistical Programmer

Katalyst HealthCares & Life Sciences

Clinical Programmer

Responsibilities:

  • Generate and validate TLFs based on the Statistical Analysis Plan, TLF specifications, and industry best practices.
  • With minimal oversight, perform all programming activities and documentation for assigned studies.
  • Follow departmental Standard Operating Procedures (SOPs) and industry guidance to ensure traceability and regulatory compliance.
  • Support the preparation and review of the electronic regulatory submission.
  • Ensure that all deliverables are completed on time and of high quality.
  • Represent the Clinical Programming function at cross-functional meetings.
  • May support EDC development and visualization tools (PowerBI).

Requirements:

  • Minimum 3-5 years in a clinical programming role.
  • Bachelor's Degree (Data Science, Computer Science, Statistics, Bioinformatics, or related discipline).
  • Independently develop SAS/R programs to generate and validate datasets according to the Statistical Analysis Plan, TLF specifications, and industry best practices.
  • Experience generating outputs for regulatory submissions (FDA) MUST.
  • Programming experience in SQL, JSON (Good to have).
  • Working experience with relational databases. (EDC system, IBM (Zelta).
  • Experience implementing CDISC standards is desirable.
  • Knowledge of EDC development and visualization tools (PowerBI, Tableau) is an asset.
  • Excellent Communications skills, both oral and written.
  • Analytical skills, creativity and innovative approach to problem solving.
  • Propensity for continuous learning and experimentation.
  • Demonstrated initiative and problem-solving skills, critical thinking skills.
Vacancy posted 5 days ago
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