Remote Staff Biostatistician — CDx/IVD Validation Lead

Natera; Oregon; Hybrid; USD 164,000 - 205,000; Full time

Job summary

Natera is seeking a Staff Biostatistician to lead the design, analysis, and interpretation of clinical validation studies for regulatory approvals, including CDx and other IVD submissions.

You will drive statistical methodologies that meet FDA standards, collaborate with Clinical Science, Data Management, and Product teams, and mentor junior staff while advancing germline and kidney disease projects. Remote USA options may apply.

Qualifications

• Ph.D. or Master's in Biostatistics, Statistics, or 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

Responsibilities

• Lead the design, analysis, and interpretation of clinical validation studies for regulatory approvals (CDx, 510(k), PMA).
• Ensure statistical methodologies meet FDA standards and interact with regulatory authorities.
• Prepare SAPs, reports, and presentations for cross-functional and external collaborators and stakeholders.
• Serve as the statistical lead on high-priority project teams and collaborate with Clinical Science, Data Management, and Product teams.
• Drive design and execution of high-impact clinical validation studies and publications.
• Stay current with advancements in Biostatistics and clinical validation methodology, implementing innovative approaches.
• Mentor and provide technical supervision to junior team members

Skills

Statistical analysis

Regulatory experience

Cross-functional collaboration

Mentoring

Communication skills

Education

Ph.D. or Master's in Biostatistics or related field

Tools

R

NGS data analysis

Job description

Natera is seeking a Staff Biostatistician to lead the design, analysis, and interpretation of clinical validation studies for regulatory approvals, including CDx and other IVD submissions.

You will drive statistical methodologies that meet FDA standards, collaborate with Clinical Science, Data Management, and Product teams, and mentor junior staff while advancing germline and kidney disease projects. Remote USA options may apply.