Senior Statistical Programmer Consultant, Oncology

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• 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 client programming standards. • Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.

🎯 Requirements

• 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.

🏖️ Benefits

• Health insurance • Professional development opportunities • Flexible work arrangements