Manager, Statistical Programming: Trials & Submissions

Natera; United States; Remote; USD 132,000 - 165,000; Full time

Benefits offered by this job

Comprehensive benefits

Free testing for employees and their家庭

401k benefits and commuter benefits

Job summary

Natera is seeking a Manager of Statistical Programming to advance our oncology diagnostics portfolio. You will lead programming deliverables (ADS, TLF) and ensure regulatory compliance across trials and submissions, leveraging your R skills and trial experience.

The role may manage a small team, develop R packages, and build Shiny dashboards to support data review and monitoring. Remote work from the USA is supported.

Qualifications

• Bachelor’s in Statistics, Mathematics, Computer Science, or a related field.
• 5+ years of related experience, with at least 3 years of experience in Clinical Trial analysis.
• At least 3 years of R programming experience, including package development.

Responsibilities

• Lead and oversee statistical programming deliverables, including ADS and TLF, ensuring data integrity and regulatory compliance with ICH, GCP, and FDA 21 CFR Part 11.
• May manage a team of statistical programmers, taking responsibility for their technical and professional development, while contributing hands‑on to programming work.
• Act as primary programming lead for regulatory submissions (e.g., 510(k), CTA/CDx, and PMA), ensuring all deliverables meet rigorous global standards.
• Maintain programming infrastructure, including R package development, validation, and maintenance in a controlled environment.
• Develop R Shiny dashboards that support data review, study monitoring, and exploration of analysis results.
• Promote statistical programming development and validation best practices.
• Work cross‑functionally with Biostats, Data Management, Clinical Science, and other functions as necessary.

Skills

R programming

Team leadership

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's in Statistics/Mathematics/CS or related

Tools

R package development

Job description

Natera is seeking a Manager of Statistical Programming to advance our oncology diagnostics portfolio. You will lead programming deliverables (ADS, TLF) and ensure regulatory compliance across trials and submissions, leveraging your R skills and trial experience.

The role may manage a small team, develop R packages, and build Shiny dashboards to support data review and monitoring. Remote work from the USA is supported.