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The Standard of Excellence
Principal Statistical Programmer – Analyst Consultant
Location
United States
Posted
103 days ago
Salary
0
Seniority
Lead
Job Description
Principal Statistical Programmer – Analyst Consultant
ClinChoice
• Lead programming activities for oncology clinical trials across multiple studies. • Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines. • Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions. • Provide SAS programming expertise to support complex data derivations and analyses. • Review and ensure traceability, consistency, and quality of all programming deliverables. • Act as programming lead for assigned studies, managing timelines and deliverables. • Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs. • Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards. • Support integrated analyses including ISS/ISE. • Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides. • Ensure all programming meets regulatory requirements (FDA, EMA, PMDA). • Contribute to responses for regulatory queries and data requests.
Job Requirements
- Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
- 8–12+ years of statistical programming experience in pharma/biotech or CRO.
- Expert-level proficiency in SAS.
- Strong understanding of CDISC SDTM and ADaM standards.
- Significant experience supporting oncology clinical trials (hematologic or solid tumors).
- Experience supporting regulatory submissions and preparing submission-ready outputs.
- Excellent communication skills and ability to collaborate cross-functionally.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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