Senior Statistical Programmer Consultant (Oncology) Remote
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Responsibilities
- Technical Leadership
- 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.
- Project & Study Management
- 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 .
- Regulatory & Submission Support
- 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.
- Required Qualifications
- 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.
- The Application Process
- Who will you be working for?
- About ClinChoice
- Our Company Ethos
- ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Benefits
Additional Information
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds... ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients. The Senior Statistical Programmer will serve as a senior technical expert responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors. This role requires advanced expertise in SAS , familiarity with R , deep knowledge of CDISC standards , and strong experience working on oncology studies and regulatory submissions.
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