Director Of Biostatistics (Oncology)

TL;DR

Director of Biostatistics (Oncology): Leading a team of statisticians to advance molecular oncology tests with an accent on analytical validation, regulatory compliance, and cross-functional collaboration. Focus on designing complex statistical studies, mentoring high-performing teams, and driving data-informed decision-making for FDA-regulated diagnostic products.

Location: Must be based in the USA (Remote)

Salary: $193,600 - $242,000 USD

Company

hirify.global is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.

What you will do

• Build, mentor, and direct a high-performing biostatistics team.
• Oversee the design, statistical analysis, and interpretation of analytical validation studies.
• Partner with bench scientists, regulatory, and product development teams to integrate statistical expertise.
• Prepare high-quality protocols and reports for internal and external stakeholders.
• Lead statistical interactions with regulatory agencies such as CAP/CLIA and the FDA.
• Promote departmental standards for statistical analysis and strategic innovation.

Requirements

• Minimum 8 years of industry experience, with at least 5 years in diagnostics.
• At least 5 years of experience leading a team.
• Master’s degree in statistics or biostatistics (PhD preferred).
• Expert knowledge of statistical methodology in diagnostic devices and FDA guidelines.
• Proven track record of cross-functional collaboration and high-quality technical documentation.
• Experience directly interacting with regulatory agencies.

Culture & Benefits

• Comprehensive medical, dental, vision, life, and disability plans.
• Free genetic testing for employees and immediate families.
• Fertility care benefits and pregnancy/baby bonding leave.
• 401k benefits and commuter benefits.
• Generous employee referral program.
• Commitment to a diverse and inclusive workplace environment.