Remote Senior Biostatistician, IVD Analytics & Validation

Natera, Inc.; United States; Remote; USD 131,000 - 164,000; Full time

Benefits offered by this job

Medical, dental, vision

Life and disability plans

401k benefits

Fertility care benefits

Job summary

Natera, Inc. is seeking a Lead Biostatistician to oversee design, analysis, and interpretation of R&D and analytical validation studies for complex biomarkers used in cancer management.

You will apply applied statistics and IVD expertise in a regulated environment, contributing to CLIA LDT and external approvals across several pathways. The role emphasizes mentoring junior staff, presenting results, and collaborating with cross-functional teams.

Qualifications

• Master’s degree in biostatistics or equivalent with 5+ years of relevant experience, or PhD with 3+ years of relevant experience
• Minimum of 4 years practical experience with R (required) and SAS or JMP
• Experience designing and executing statistical analyses in a regulated environment

Responsibilities

• Lead Biostatistics efforts designing and executing analyses for analytical validation studies in support of CLIA LDT and in vitro diagnostic approvals (e.g., IVDR, 510(k), PMA, etc.)
• Perform relevant statistical analyses (e.g., sample size, power, agreement, precision, LoD calculations) for validation studies of varying complexity
• Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation
• Effectively convey statistical concepts and results to cross-functional internal and external collaborators and stakeholders
• Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams
• Mentor and provide technical supervision to junior team members

Skills

Biostatistics expertise

Statistical analysis

Regulatory environment knowledge

Communication skills

Mentoring

Education

Master’s degree in biostatistics

PhD in biostatistics

Tools

R

SAS

JMP

Job description

Natera, Inc. is seeking a Lead Biostatistician to oversee design, analysis, and interpretation of R&D and analytical validation studies for complex biomarkers used in cancer management.

You will apply applied statistics and IVD expertise in a regulated environment, contributing to CLIA LDT and external approvals across several pathways. The role emphasizes mentoring junior staff, presenting results, and collaborating with cross-functional teams.