Principal Statistical Programmer / Analyst Consultant - Oncology
C
ClinChoicePharma/Biotech
United StatesPrincipal
Salary not disclosed
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Job Details
- Experience
- 8–12+ years
- Required Skills
- R
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
Responsibilities
- 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
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