Manager of Statistical Programming

This is an exciting opportunity to participate in advancing Natera’s oncology product portfolio of cutting-edge diagnostic tests. As Manager of Statistical Programming, you will leverage your strong R programming skills and clinical trials background to contribute to the analysis and reporting of clinical trials supporting multiple regulatory submissions.

Primary Responsibilities:

• Lead and oversee statistical programming deliverables, including ADS (Analysis Datasets) and TLF (Table, Listings and Figures), 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.

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.

Knowledge, Skills, and Abilities:

• Proficient in R programming, including building and maintaining packages.
• Experience in analysis dataset and TLF generation.
• Prior experience in NGS, genetics, and/or oncology diagnostics preferred.
• Experience maintaining statistical computing environments a plus.