Statistical Programmer

2 months ago

San Francisco, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities:

  • Lead the development, validation, and maintenance of statistical programs using SAS to generate tables, listings, and figures (TLFs) for clinical trial data analysis.

  • 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.

Requireme nts:
  • Minimum of a bachelor's degree required; MS degree is preferred. (statistics, biostatistics, or closely related field)
  • 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.

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