Principal Statistical Programmer Consultant – Oncology (Remote – US)
Location: United States (Remote)
Employment Type: Contract / Full-Time
Experience Required: 8–12+ Years in Statistical Programming / Oncology Clinical Trials
Educational Qualification: Bachelor’s or Master’s in Statistics, Computer Science, Mathematics, Life Sciences, or related field
Job Overview
ClinChoice, a global full-service CRO, is seeking a Principal Statistical Programmer Consultant – Oncology to join a client-centric clinical development team. This senior-level role combines technical programming expertise, project leadership, and team oversight, ensuring high-quality, traceable programming outputs for oncology clinical trials.
The ideal candidate brings advanced experience in SAS, CDISC standards (SDTM/ADaM), oncology trial datasets, and regulatory submission support, with a proven ability to collaborate across cross-functional teams, external vendors, and clients.
Key Responsibilities
Technical Leadership
Lead statistical programming activities for oncology studies across multiple trials.
Develop, validate, and maintain SDTM and ADaM datasets according to CDISC guidelines.
Oversee creation of Tables, Listings, and Figures (TLFs) for study reporting and regulatory submissions.
Provide advanced SAS programming expertise for complex data derivations and analyses.
Ensure traceability, quality, and consistency of all programming deliverables.
Project & Study Management
Act as programming lead for assigned oncology studies, managing timelines and deliverables.
Collaborate with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs teams.
Coordinate with CROs and external vendors, ensuring compliance with programming standards.
Support integrated analyses, including ISS/ISE preparation.
Regulatory & Submission Support
Prepare submission-ready programming outputs, 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 in Statistics, Computer Science, Mathematics, Life Sciences, or a related field.
8–12+ years of statistical programming experience in pharmaceutical, biotechnology, or CRO environments.
Expert-level proficiency in SAS; working knowledge of R is advantageous.
Strong knowledge of CDISC SDTM and ADaM standards.
Hands-on experience with oncology clinical trials (solid tumors or hematologic).
Experience supporting regulatory submissions and preparing submission-ready outputs.
Excellent communication and collaboration skills.
Preferred Qualifications
Demonstrated technical leadership in multi-study oncology trials.
Experience translating complex datasets for non-technical stakeholders.
Located in North America or similar time zones for client collaboration.
Why Join ClinChoice?
Work directly with a single sponsor while leveraging the resources of a global CRO.
Drive innovative oncology drug development and data-driven clinical decisions.
Join a diverse and inclusive workplace that values expertise, growth, and collaboration.
Access continuous training and development programs to enhance clinical programming leadership skills.
Apply now to join ClinChoice as a Principal Statistical Programmer Consultant – Oncology and contribute to life-changing oncology clinical trials globally.
Explore more clinical data science, statistical programming, and oncology CRO opportunities at thepharmadaily.com.
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