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Principal Statistical Programmer

Katalyst HealthCares & Life Sciences
Walnut Creek, CA
Full-time

Responsibilities :

  • Works regularly with advanced features of SAS (including interfacing ability with other software applications and operating system tools).
  • Performs quality control checks of SAS code and output produced by other Statistical Programmers to ensure accuracy and consistency within group.
  • Demonstrates in-depth knowledge of clinical development and medical data.
  • Creates all files, documents, and analyses necessary to support an electronic submission in eCTD format, including ISS / Client.
  • Provides leadership to ensure compliance with Vertex SOP'S and FDA / ICH / GCP regulations
  • Provides technical and project management skills to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
  • Participates in project management cross-functional teams that work on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies

Requirements :

  • Proficiency in all SAS language, procedures, and functions commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS / STAT and SAS / GRAPH
  • Intermediate knowledge of CDISC Standards
  • Intermediate knowledge of clinical trials
  • Regulatory submission experiences
  • Effective communication (written and verbal) skills to explain difficult information
  • Bachelor's degree in a Scientific Discipline
  • Typically requires + for or above and + years for years of work experience in Biotech, Pharmaceuticals or Clinical Research Organization
  • 30+ days ago
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