Staff Biostatistician (Clinical Validation)

📋 Description

• Independently lead the design, analysis, and interpretation of clinical validation studies to
• Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as
• Prepare comprehensive statistical analysis protocols (SAPs), reports, and presentations for
• Serve as the statistical lead on high-priority project teams. Partner with Clinical Science, Data
• Drive design and execution of high-impact research clinical trials, studies, and publications that
• Stay current with advancements in Biostatistics and clinical validation methodology, implementing

🎯 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
• Demonstrated experience in regulated environments, including previous CDx or IVD submission
• Experience with next-generation sequencing (NGS), genetic, and/or germline-related data.
• Minimum of 4 years practical experience with R statistical analysis software.

🎁 Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their
• Free testing for employees and their immediate families, in addition to fertility care benefits.
• Pregnancy and baby bonding leave.
• 401k benefits and commuter benefits.
• Generous employee referral program.