Principal Statistical Programmer Consultant – Oncology
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
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