Staff Biostatistician – Clinical Validation

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the design, analysis, and interpretation of clinical validation studies for in vitro diagnostic approvals, including CDx, 510(k), and PMA submissions independently.

• Ensure that statistical methodologies and analyses comply with FDA and other regulatory agency standards.

• Facilitate statistical interactions with regulatory authorities.

• Create statistical analysis protocols, reports, and presentations for cross-functional teams and external stakeholders.

• Act as the statistical lead on high-priority project teams.

• Collaborate with Clinical Science, Data Management, and Product teams in project planning and execution.

• Identify potential risks, communicate issues, and advocate for solutions within interdisciplinary project teams.

• Oversee the design and execution of clinical trials, studies, and publications.

• Apply innovative biostatistical and clinical validation methodologies for the development of diagnostic products and regulatory submissions.

• Mentor and provide technical guidance to junior team members.

⛳️ Requirements

• Ph.D. or Master's degree in Biostatistics, Statistics, or a related discipline.

• A minimum of 8 years of relevant industry experience, ideally in molecular diagnostics, biotechnology, or related areas.

• Proven experience in regulated environments, particularly with CDx or IVD submissions.

• Familiarity with next-generation sequencing (NGS), genetic, and/or germline-related data.

• At least 4 years of practical experience using R statistical analysis software.

• In-depth knowledge of statistical methodologies in diagnostic medicine and an understanding of FDA guidelines.

• Previous experience engaging with regulatory bodies such as the FDA.

• Demonstrated ability and enthusiasm for collaborating on cross-functional teams with individuals from diverse technical backgrounds.

• Strong history of producing high-quality written documentation for various audiences.

• Preferred experience with germline assay development.

• Desired experience related to kidney disease.

• Experience in the design and analysis of clinical validation studies.

• Excellent communication skills, capable of explaining complex statistical concepts to non-statistical audiences.

• Attention to detail and a commitment to delivering high-quality work within tight deadlines.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability plans available for eligible employees and their dependents.

• Complimentary testing for employees and their immediate families.

• Fertility care benefits offered.

• Pregnancy and baby bonding leave provided.

• 401(k) benefits available.

• Commuter benefits included.

• Employee referral program available.