Manager, Statistical Programming

🕒 October 12

🇺🇸 United States – Remote

💵 $132k - $165.3k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 Description

• 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, supporting their technical and professional development while contributing hands-on to programming work • Act as primary programming lead for regulatory submissions, including 510(k), CTA/CDx, and PMA • Maintain programming infrastructure, including R package development, validation, and maintenance in a controlled environment • Develop R Shiny dashboards supporting 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

🎯 Requirements

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

🏖️ Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents • Free testing for employees and immediate families • Fertility care benefits • Pregnancy and baby bonding leave • 401k benefits • Commuter benefits • Employee referral program

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