Lead Biostatistician – IVD Analytical

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

📋 Description

• Lead Biostatistics initiatives by designing and executing analyses for analytical validation studies that support CLIA LDT and in vitro diagnostic approvals, including IVDR, 510(k), and PMA.

• Conduct statistical analyses such as sample size, power, agreement, precision, and LoD calculations for validation studies.

• Create presentations and write documentation detailing analysis plans, methodologies, results, and interpretations.

• Communicate statistical concepts and findings to internal and external cross-functional collaborators and stakeholders.

• Identify potential risks, relay concerns, and advocate for solutions within interdisciplinary project teams.

• Mentor junior team members and provide them with technical guidance.

⛳️ Requirements

• A Master’s degree in biostatistics, statistics, or a related field with over 5 years of relevant experience, or a PhD in biostatistics, statistics, or a related field with a minimum of 3 years of relevant experience.

• Previous experience in diagnostics is essential.

• At least 4 years of hands-on experience with statistical analysis software such as R (required) and SAS or JMP.

• Experience in designing and conducting statistical analyses within a regulated setting.

• Expert knowledge of statistical methodologies in diagnostic medicine, including an understanding of CLSI guidelines.

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

• Excellent communication skills, capable of conveying complex statistical ideas to audiences without a statistical background.

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

• Prior experience with next-generation sequencing (NGS), genetics, and/or oncology diagnostics is advantageous.

• Familiarity with DNA methylation is a plus.

• Experience in negotiations with the FDA is also a plus.

🏝️ Benefits

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

• Complimentary testing for employees and their immediate families.

• Fertility care benefits.

• Maternity and baby bonding leave.

• 401k benefits.

• Commuter benefits.

• Employee referral program.