What are the responsibilities and job description for the Clinical SAS Programmer position at Fusion Life Sciences?
Job Title: Clinical SAS Programmer / CSV Specialist
Industry: Pharmaceutical / Biotechnology / Clinical Research
Employment Type: Contract - 6Months
Industry: Pharmaceutical / Biotechnology / Clinical Research
Employment Type: Contract - 6Months
Position Summary
We are seeking an experienced Clinical SAS Programmer / CSV Specialist to support clinical statistical programming, clinical data validation, and computer system validation activities in a regulated pharmaceutical or CRO environment. The ideal candidate will have strong hands-on experience with SAS programming, SDTM and ADaM dataset development, Tables, Listings, and Figures (TLFs), and regulatory submission requirements. This role will also involve authoring, reviewing, and executing CSV documentation, maintaining operational procedures, and ensuring compliance with applicable regulatory standards.
Key Responsibilities
- Develop, maintain, and validate SAS programs for clinical trial data processing, statistical analysis, and regulatory reporting.
- Create and validate SDTM and ADaM datasets in accordance with CDISC standards and study-specific specifications.
- Generate Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
- Perform SAS program validation, independent programming checks, quality control, data reconciliation, and discrepancy resolution.
- Support Computer System Validation (CSV) activities for computerized systems used in clinical research and statistical programming.
- Author, review, and execute validation documentation, including validation plans, requirements specifications, risk assessments, test scripts, traceability matrices, and validation reports, as applicable.
- Develop, review, and maintain SOPs, work instructions, and operational procedures related to clinical programming, data validation, and computerized systems.
- Ensure compliance with applicable FDA regulations, 21 CFR Part 11, GCP requirements, CDISC standards, and organizational quality procedures.
- Maintain accurate documentation, audit trails, change controls, and validation evidence to support inspections and regulatory audits.
- Collaborate with biostatisticians, clinical data management, Quality Assurance, IT, and regulatory affairs teams to resolve technical and compliance issues.
- Support system upgrades, change management, deviation investigations, and remediation activities related to validated systems.
- Identify opportunities to improve programming efficiency, automate repetitive reporting tasks, and strengthen data quality.
Required Qualifications
- Bachelor's or Master's degree in Computer Science, Statistics, Biostatistics, Life Sciences, Pharmacy, or a related field.
- 10 years of relevant experience in Clinical SAS programming, statistical programming, CSV, or regulated clinical systems, depending on the scope of responsibility.
- Strong hands-on experience with Base SAS, SAS/STAT, SAS macro programming, and clinical data processing.
- Experience developing SDTM and ADaM datasets and generating TLFs for clinical trials.
- Knowledge of CDISC standards, including SDTM and ADaM, and clinical study reporting requirements.
- Experience with SAS program validation, QC checks, independent programming, and documentation.
- Working knowledge of CSV principles, risk-based validation, change control, and software/system lifecycle documentation.
- Familiarity with FDA 21 CFR Part 11, GCP, data integrity, and applicable regulatory requirements.
- Strong technical writing, analytical, documentation, and cross-functional communication skills.