Job Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

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.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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