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Role Description
The Principal 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.
• 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 Kite’s 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.
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.
Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Company Description
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
• Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
• Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built.
• Close management and training is the core instrument to develop and maintain highly-qualified personnel.
• The continuous training keeps the resources qualified in terms of competence and expertise.
• ClinChoice is an equal opportunity employer, guided by diversity and inclusivity.