Job Description

• 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.

• 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.

Job Tags

Similar Jobs