Senior Statistical Programmer Consultant (Oncology)
C
ClinChoiceClinical Research
United StatesFull-TimeSenior
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.
- Ability to provide study leadership and oversee internal teams and external vendors.
- 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.
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