We are seeking an experienced Statistical Programmer to support clinical development programs by creating high-quality analysis datasets and regulatory-compliant outputs. The role involves close collaboration with biostatistics, clinical, and data management teams to ensure accurate, efficient, and compliant delivery of programming deliverables.
Key Responsibilities
- Develop SAS programs to create derived analysis datasets and outputs for Tables, Listings, and Figures (TLFs)
- Perform programming validation to ensure accuracy and quality of datasets and outputs
- Provide programming support to project teams including:
- Programming strategies
- Standards and specifications
- Analysis programming
- Support electronic submission preparation and review
- Review key planning documents (SAP, Data Presentation Plan, Data Review Plan) to ensure:
- Alignment with development objectives
- Clarity of programming assumptions and requirements
- Assessment of impact on programming activities
- Collaborate with external vendors on programming standards, conventions, specifications, and file transfers
- Ensure quality of Global Biometric and Data Sciences (GBDS) deliverables by applying standards and complying with:
- Regulatory requirements
- Corporate and departmental SOPs
- Identify opportunities to improve efficiency and consistency across GBDS and vendor interactions
- Independently lead and execute programming assignments with minimal supervision
- Support continuous process improvement initiatives
Skills, Knowledge & Experience
Minimum Requirements
- Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, or Life Sciences
- 8+ years of programming experience in the clinical / pharmaceutical industry
- Strong proficiency in SAS analytical programming
- In-depth understanding of clinical data standards (CDISC SDTM, ADaM) and relational databases
- Hands-on experience with:
- Upstream data handling (eDC, SDTM, multiple data forms, workflows)
- Downstream deliverables (ADaM, Data Definition Tables, e-submissions)
- Experience with Pinnacle 21, XML, MS Office
- Good understanding of:
- Regulatory and industry standards
- Statistical terminology and clinical trial designs
- Medical terminology and clinical tests
- Strong teamwork and collaboration skills with clinical and biostatistics teams
Preferred Requirements
- 10+ years of clinical/statistical programming experience supporting regulatory filings (NDA, BLA, MAA)
- Knowledge of the drug development lifecycle and global regulatory requirements
- Experience with R programming
- Working knowledge of Linux/Unix environments
