Staff Biostatistician (Clinical Validation)

Location: US Remote

Salary: $164,000–$205,000 USD per year

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, analysis, and interpretation of clinical validation studies supporting IVD approvals, including CDx, 510(k), and PMA submissions.
• Ensure statistical methodologies and analyses meet FDA and other regulatory standards, and support interactions with regulatory authorities.
• Prepare statistical analysis plans, reports, presentations, and other documentation for internal and external stakeholders.
• Act as the statistical lead for cross-functional projects with Clinical Science, Data Management, and Product teams.
• Design and execute clinical research studies and publications involving molecular diagnostics, germline projects, and kidney disease.
• Mentor and provide technical supervision to junior team members while applying current biostatistical and clinical validation methods.

Requirements

• Ph.D. or master’s degree in Biostatistics, Statistics, or a related field.
• At least 8 years of relevant industry experience, preferably in molecular diagnostics, biotechnology, or a related field.
• Experience working in regulated environments, including CDx or IVD submissions and interaction with the FDA.
• Experience with next-generation sequencing, genetic, or germline-related data.
• At least 4 years of practical experience using R for statistical analysis.
• Strong knowledge of diagnostic medicine methodology, clinical validation studies, technical documentation, and cross-functional communication.

Nice to have

• Experience with germline assay development.
• Experience in kidney disease research.

Culture & Benefits

• Work in a multidisciplinary environment with statisticians, geneticists, physicians, laboratory scientists, software engineers, and other specialists.
• Medical, dental, vision, life, and disability insurance 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, and commuter benefits.
• Inclusive workplace focused on improving genetic disease management and patient care.