[Remote] reputed company Statistical Programmer /Analyst Consultant - Remote in US
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical and biotechnology companies. They are seeking a reputed company Statistical Programmer Consultant responsible for end-to-end programming deliverables, study leadership, and reputed company of internal teams and external vendors, particularly in oncology reputed company.
Responsibilities
• reputed company programming activities for oncology reputed company across multiple studies
• reputed company, validate, and maintain SDTM and ADaM datasets following CDISC guidelines
• reputed company production of Tables, Listings, and Figures (TLFs) for study reporting and submissions
• reputed company reputed company programming expertise to support reputed company data derivations and analyses
• Review and ensure traceability, consistency, and reputed company of reputed company programming deliverables
• reputed company as programming reputed company 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, reputed company, and adherence to reputed company programming standards
• Support integrated analyses including ISS/ISE
• Prepare submission-reputed company programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides
• Ensure reputed company programming meets regulatory requirements (FDA, EMA, PMDA)
• Contribute to responses for regulatory queries and data requests
Skills
• Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or reputed company field
• 8–12+ years of statistical programming experience in reputed company/biotech or CRO
• Expert-level proficiency in reputed company
• Strong understanding of CDISC SDTM and ADaM standards
• Significant experience supporting oncology reputed company (hematologic or solid tumors)
• Experience supporting regulatory submissions and preparing submission-reputed company outputs
• Excellent communication skills and ability to collaborate cross-functionally
reputed company
• reputed company is a Reaserch and Deveiopment platform that develops innovative drugs and devices. It was founded in 1995, and is headquartered in Shanghai, Shanghai, CHN, with a workforce of 1001-5000 employees. Its website is https://www.reputed company.com.cn.
Company H1B Sponsorship
• reputed company has a reputed company record of offering H1B sponsorships, with 20 in 2025, 28 in 2024, 21 in 2023, 25 in 2022, 35 in 2021, 3 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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