Statistical Programmer | Remote
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WE’RE HIRING: STATISTICAL PROGRAMMER | REMOTE
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.
KEY RESPONSIBILITIES
- 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.
KEY QUALIFICATIONS
- 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.
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