Staff Biostatistician (MedTech)

TL;DR

Staff Biostatistician (MedTech): Leading biostatistics efforts for oncology molecular diagnostic tests with an accent on analytical validation study design and execution. Focus on driving the strategy for complex validation experiments and ensuring regulatory compliance with FDA and CLSI standards.

Location: Remote (USA)

Salary: $164,000 – $205,000

Company

hirify.global is a global leader in cell-free DNA (cfDNA) testing, specializing in oncology, women's health, and organ health diagnostics.

What you will do

• Lead the design, analysis, and interpretation of analytical validation studies for oncology products.
• Serve as the statistical lead on high-priority projects, collaborating with bench scientists, bioinformatics, and product development teams.
• Prepare comprehensive protocols and reports for cross-functional stakeholders and collaborators.
• Ensure all statistical methodologies and analyses comply with standards from CAP/CLIA, NYS, and the FDA.
• Drive the application of common and cutting-edge statistical methods for studies of varying complexity.

Requirements

• Minimum 8 years of industry experience in analytical validation within diagnostics, biotechnology, or related fields.
• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.
• Expert knowledge of statistical methodology in diagnostic medicine and deep understanding of CLSI guidelines.
• Must be based in the United States.
• Exemplary written and verbal communication skills for presenting technical data to executive leadership.

Culture & Benefits

• Comprehensive medical, dental, vision, life, and disability insurance plans.
• Free genetic testing for employees and their immediate families.
• 401k benefits and commuter assistance.
• Pregnancy and baby bonding leave.
• Fertility care benefits.