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Principal Statistical Programmer Consultant – Oncology

Remote, USA Full-time Posted 2025-11-24
Job Description: • 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 Kite’s programming standards. • Support integrated analyses including ISS/ISE. • Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides. 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 • 401(k) retirement plan • Paid time off • Flexible work arrangements • Professional development opportunities Apply tot his job Apply To this Job

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