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We are looking for a skilled Statistical Programmer to support clinical research studies through statistical programming, clinical data validation, and the development of high-quality statistical deliverables.

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• Develop, maintain, and validate SDTM and ADaM datasets for clinical trials.

• Program Tables, Listings, and Figures (TLFs) for interim analyses, data monitoring, and clinical study reports.

• Develop and validate annotated Case Report Forms (aCRFs).

• Perform data cleaning activities and resolve statistical data issues in collaboration with Data Management and Biostatistics teams.

• Develop and maintain dataset specifications, Define-XML, and Reviewer's Guides.

• Validate SDTM and ADaM datasets using Pinnacle 21.

• Utilize SAS macros and programming standards to improve efficiency and quality.

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• Bachelor's degree in Statistics, Computer Science, or a related field.

• At least 1 year of clinical research experience, including 1 year of Statistical Programming experience in the biotechnology, pharmaceutical, or CRO industry.

• Strong working knowledge of SAS.

• Good knowledge of CDISC standards (SDTM and ADaM).

• Exposure to clinical trial data, Statistical Analysis Plans (SAP), TLF Shells, and programming specifications.

• Knowledge of Pinnacle 21 and XML programming is an advantage.

• Familiarity with ICH guidelines, GCP, and FDA/Health Canada regulatory requirements.

• Excellent analytical, organizational, and problem-solving skills.