Lead Biostatistician (IVD Analytical)

Location: US Remote; United States

Salary: USD 130,900–163,600

Company

hirify.global develops cell-free DNA testing and personalized genetic diagnostics for oncology, women’s health, and organ health.

What you will do

• Lead the design, execution, analysis, and interpretation of analytical validation studies for CLIA LDT and in vitro diagnostic approvals, including IVDR, 510(k), and PMA submissions.
• Perform sample size, power, agreement, precision, and limit-of-detection analyses for validation studies of varying complexity.
• Prepare analysis plans, statistical methods, results, interpretations, presentations, and high-quality documentation.
• Communicate statistical concepts and findings to internal and external cross-functional collaborators and stakeholders.
• Identify risks, communicate concerns, and champion solutions within interdisciplinary project teams.
• Mentor and provide technical supervision to junior team members.

Requirements

• Master’s degree in biostatistics, statistics, or an equivalent field with 5+ years of relevant experience, or PhD in biostatistics, statistics, or an equivalent field with 3+ years of relevant experience.
• Previous diagnostic experience and experience designing and executing statistical analyses in a regulated environment.
• At least 4 years of practical experience with R, which is required, and SAS or JMP.
• Expert knowledge of statistical methodology in diagnostic medicine, including CLSI guidelines.
• Ability and enthusiasm to work on cross-functional teams with diverse technical backgrounds.
• Strong communication skills for explaining complex statistical concepts to non-statistical audiences.
• Strong record of producing high-quality written documentation for multiple audiences.

Nice to have

• Experience negotiating with the FDA.
• Experience with next-generation sequencing, genetics, and/or oncology diagnostics.
• Familiarity with DNA methylation.

Culture & Benefits

• Full-time remote work in the United States.
• Medical, dental, vision, life, and disability plans for eligible employees and dependents.
• Free testing for employees and immediate family members, plus fertility care benefits.
• Pregnancy and baby bonding leave, 401(k) benefits, commuter benefits, and an employee referral program.
• Inclusive collaboration across statisticians, geneticists, physicians, laboratory scientists, software engineers, and other professionals.