Statistical Programmer

2 weeks ago


San Francisco, California, United States Katalyst Healthcares & Life Sciences Full time
{"title": "Statistical Programmer", "content": "Job Summary

Katalyst Healthcares & Life Sciences is seeking a skilled Statistical Programmer to lead the development, validation, and maintenance of statistical programs using SAS. The ideal candidate will have a strong background in clinical programming, CDISC standards, and regulatory submission requirements.

Key Responsibilities
  • Develop and maintain SDTM domains in accordance with CDISC guidance.
  • Create and optimize ADaM datasets, Tables, Figures, Listings (TFLs) and Analysis content.
  • Support the creation of statistical outputs for clinical study reports (CSRs), regulatory submissions, and publications.
  • Prepare documentation for regulatory submissions, including electronic submissions to the FDA and other global health authorities.
  • Perform data cleaning, validation, and preparation tasks to ensure high-quality datasets for analysis.
  • Prepare and maintain thorough documentation of programming activities, including specifications, programming code, and validation reports.
  • Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
  • Establish and implement statistical programming standards and comply with industry standards and regulatory requirements among project team members and across all studies.
Requirements
  • Minimum of a bachelor's degree required; MS degree is preferred.
  • 5 years' experience with SAS and clinical programming within the biotech / pharmaceutical industry.
  • Proficiency in SAS programming, including experience with SAS macro language, data step programming, and PROC SQL.
  • Strong knowledge of CDISC and CDASH standards, including SDTM and ADaM datasets, and experience with regulatory submission requirements.
  • Experience with clinical trial data and understanding of the drug development process.
  • Proficiency in industry standards, medical terminology, and clinical trial methodologies.
  • Excellent problem-solving skills and attention to detail, with the ability to work independently and manage multiple projects simultaneously.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
", "lang_code": "en-US"}

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