Statistical Programmer Job at cGxPServe, Chicago, IL

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  • cGxPServe
  • Chicago, IL

Job Description

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.
Requirements:
  • 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.
  • Knowledge of regulatory guidelines, including FDA, EMA, and ICH, related to statistical programming and clinical trials.
  • Experience with statistical programming development, validation, execution, maintenance, documentation, and archival of clinical data for regulatory submission is required.

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