Staff Biostatistician – Clinical Validation

🔥 8 minutes ago

🇺🇸 United States – Remote

💵 $164k - $205k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

🦅 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

• Independently lead the design, analysis, and interpretation of clinical validation studies supporting in vitro diagnostic approvals, including CDx, 510(k), and PMA submissions • Ensure statistical methodologies and analyses meet FDA and other regulatory agency standards • Drive statistical interactions with regulatory authorities • Prepare statistical analysis protocols, reports, and presentations for cross-functional and external collaborators and stakeholders • Serve as statistical lead on high-priority project teams • Partner with Clinical Science, Data Management, and Product teams on project planning and execution • Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams • Drive the design and execution of clinical trials, studies, and publications • Implement innovative biostatistical and clinical validation methodologies for diagnostic product development and regulatory submissions • Mentor and provide technical supervision to junior team members

🎯 Requirements

• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field • At least 8 years of relevant industry experience, preferably within molecular diagnostics, biotechnology, or related fields • Demonstrated experience in regulated environments, including previous CDx or IVD submission experience • Experience with next-generation sequencing (NGS), genetic, and/or germline-related data • Minimum of 4 years practical experience with R statistical analysis software • Expert working knowledge of statistical methodology in diagnostic medicine, including an understanding of FDA guidelines • Previous experience interacting with regulatory bodies such as the FDA • Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds • Strong track record of producing high quality written documentation for multiple audiences • Prior experience with germline assay development preferred • Prior experience with kidney disease desired • Experience in design and analyses of clinical validation studies • Strong communication skills, with the ability to explain complex statistical concepts to non-statistical audiences • Attention to detail and a commitment to delivering high-quality work under tight deadlines

🏖️ Benefits

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