Lead Statistical Programmer - R & Regulatory Submissions

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

Benefits offered by this job

Medical, dental, vision

Life and disability plans

401k retirement plan

Fertility care benefits

Parental leave

Commuter benefits

Employee referral program

Job summary

Natera is seeking a Manager of Statistical Programming to lead deliverables for oncology trials, drive regulatory submissions, and advance statistical computing infrastructure. You will mentor programmers, oversee ADS and TLF production, and develop R packages and Shiny dashboards to support study review and monitoring.

The role requires strong R expertise and clinical trial experience, with emphasis on data integrity, regulatory standards, and cross-functional collaboration across

Qualifications

• Strong R programming skills with package development experience.
• Experience analyzing clinical trial data for regulatory submissions.
• Leadership of statistical programmers and mentoring.
• Familiarity with ICH, GCP, and 21 CFR Part 11 compliance.

Responsibilities

• Lead statistical programming deliverables (ADS, TLF) ensuring data integrity and regulatory compliance.
• May manage a team of programmers and contribute hands-on programming work.
• Serve as primary programming lead for regulatory submissions (510(k), CTA/CDx, PMA).
• Maintain programming infrastructure including R package development and validation.
• Develop R Shiny dashboards to support data review and study monitoring.
• Promote best practices in programming development and validation.
• Collaborate cross-functionally with Biostats, Data Management, and Clinical Science.

Skills

R programming

Clinical trial analysis

Team leadership

Regulatory submissions

Data analysis

Education

Bachelor's in Statistics / Mathematics / CS

Tools

R

R Shiny

R package development

Validation workflows

Job description

Natera is seeking a Manager of Statistical Programming to lead deliverables for oncology trials, drive regulatory submissions, and advance statistical computing infrastructure. You will mentor programmers, oversee ADS and TLF production, and develop R packages and Shiny dashboards to support study review and monitoring.

The role requires strong R expertise and clinical trial experience, with emphasis on data integrity, regulatory standards, and cross-functional collaboration across