ClinChoice · 4 hours ago
1482# Principal Statistical Programmer Consultant(Oncology) - Remote in US
United States
Contract
Remote
Lead/Staff
8+ years expClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They are seeking a Principal Statistical Programmer Consultant to provide technical leadership for oncology clinical trials, manage programming deliverables, and ensure compliance with regulatory requirements.
BiotechnologyConsultingHealth CarePharmaceutical
Hiring Manager
Timothy Tanaka
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 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
Qualification
Required
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
Company
ClinChoice
ClinChoice is a Reaserch and Deveiopment platform that develops innovative drugs and devices.
1001-5000 employees
H1B Sponsorship
ClinChoice has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (28)
2023 (21)
2022 (25)
2021 (35)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
$212MKey Investors
Legend CapitalGoldman Sachs
2022-07-04Series E· $150M
2019-10-25Series D· $62M
2019-05-01Series C
Leadership Team
John Balian, MD
Chief Executive Officer
Recent News
2025-11-18
2023-07-18
Bloomberg.com
2023-07-07
Company data provided by crunchbase