Lead Biostatistician (Oncology)

TL;DR

Lead Biostatistician (Oncology): Overseeing the design, analysis, and interpretation of clinical trials for regulated molecular diagnostic products with an accent on oncology portfolio submissions. Focus on statistical methodology, regulatory compliance, and cross-functional collaboration to advance personalized genetic testing.

Location: Must be based in San Carlos, CA

Salary: $144,000 - $180,000 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

• Design and review statistical methodology in protocols and statistical analysis plans.
• Lead the execution of statistical analyses for clinical trials and regulatory submissions.
• Produce high-quality presentations and author documentation of analysis plans and results.
• Convey complex statistical concepts to cross-functional internal and external stakeholders.
• Identify project risks and champion solutions within interdisciplinary teams.
• Mentor and provide technical supervision to junior team members.

Requirements

• Master’s degree in biostatistics or statistics with 5+ years of experience, or PhD with 3+ years of experience.
• At least 3 years of practical experience in a regulated clinical trial environment.
• Minimum of 4 years of experience with statistical software such as R, SAS, or JMP.
• Expert knowledge of probability theory and statistical methods.
• Familiarity with regulatory standards in clinical trial design.
• Strong communication skills for technical and non-technical audiences.

Nice to have

• Previous diagnostic or IVD experience.
• Experience with next-generation sequencing (NGS), genetics, or oncology testing.
• Prior experience interacting with regulatory bodies such as the FDA.

Culture & Benefits

• Comprehensive health benefits including medical, dental, and vision.
• 401(k) retirement plan with company match.
• Annual performance incentive bonus and long-term equity awards.
• Generous paid time off and company holidays.
• Free testing for employees and immediate families plus fertility care benefits.