Client is seeking an experienced Clinical SAS Validation & Computer System Validation (CSV) Consultant with 10+ years of experience in the use and validation of Clinical SAS for statistical programming and the generation of Tables, Listings, and Figures (TLFs) for regulatory submissions.
The consultant will provide expertise in advising, authoring, and executing Computer System Validation (CSV) documentation and operational procedures to support compliant, reliable, and validated clinical statistical programming processes.
Key Responsibilities
- Provide subject matter expertise in the use and validation of Clinical SAS for statistical programming and regulatory submissions.
- Support the generation and validation of Tables, Listings, and Figures (TLFs) used in clinical study reports and regulatory submissions.
- Advise on CSV strategies, validation approaches, documentation requirements, and operational procedures.
- Author, review, and execute CSV documentation in accordance with applicable quality and regulatory requirements.
- Develop and maintain validation plans, protocols, test scripts, test evidence, traceability documentation, and validation reports, as applicable.
- Assess Clinical SAS processes and supporting systems to ensure they operate as intended and produce reliable, accurate, and reproducible outputs.
- Support validation testing, document execution results, investigate discrepancies, and assist with deviation resolution.
- Develop and improve standard operating procedures (SOPs), work instructions, and operational procedures related to Clinical SAS and computer system validation.
Pay: $55.00 - $70.00 per hour
Expected hours: 40.0 per week
Work Location: Remote
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