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Senior Statistical Programmer Consultant (Oncology) Remote

External
Full-timeOn-site1d ago
Clinical TrialsComplianceDocumentationLeadershipSAS
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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

Health insurance

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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