Job Details

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Position Summary

A clinical-stage biotech company based in the Bay Area is seeking a Senior Statistical Programmer to provide long-term contract support. The organization is focused on the development of oncology therapeutics, and with a growing pipeline, the programming team requires additional senior-level expertise.

This role will specifically focus on CDISC SDTM standards, requiring deep, hands-on experience in SDTM mapping and implementation for oncology clinical trials. The ideal candidate will be a subject matter expert in SDTM who can lead dataset development efforts, ensure regulatory compliance, and provide technical guidance to cross-functional teams.

Key Responsibilities

• Lead the development, mapping, and implementation of CDISC SDTM datasets for oncology clinical studies.
• Translate raw clinical data into compliant SDTM domains according to CDISC standards and sponsor requirements.
• Develop and maintain SDTM specifications and mapping documentation.
• Perform hands-on SAS programming to create, validate, and quality control SDTM datasets.
• Ensure SDTM deliverables are submission-ready and compliant with regulatory standards.
• Collaborate with Biostatistics, Data Management, and Clinical teams to resolve data and mapping issues.
• Review CRFs, CRF annotations, and protocols to ensure accurate SDTM mapping.
• Support regulatory submissions and respond to data-related queries as needed.

Top Requirements

• 10–15+ years of statistical programming experience in clinical research, preferably with small to mid-sized sponsor companies
• Extensive expertise in CDISC SDTM standards with strong hands-on SDTM mapping and implementation experience for oncology trials
• Oncology experience required, with solid tumor experience strongly preferred (RECIST criteria)
• Advanced SAS programming skills with a focus on SDTM dataset creation and validation.
• Experience preparing SDTM datasets for regulatory submissions (e.g., FDA/EMA).
• Ability to work independently and serve as an SDTM subject matter expert within the programming team.
• Excellent communication skills and ability to collaborate effectively in a cross-functional environment.