Staff Biostatistician (Analytical Validation)

Description:

• Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products.
• Serve as the statistical lead on multiple high-priority project teams.
• Partner with bench scientists, bioinformatics, and product development teams to integrate statistical input into project planning and execution.
• Identify project risks, communicate statistical concerns, and help drive solutions across interdisciplinary teams.
• Prepare protocols, reports, and other documentation for collaborators and stakeholders.
• Ensure statistical methods and analyses meet CAP/CLIA, NYS, and FDA regulatory standards.
• Provide leadership on the use of both established and advanced statistical methods for studies of varying complexity.

Requirements:

• Minimum 8 years of relevant industry experience in analytical validation within diagnostics, biotechnology, or a related industry.
• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.
• Expert-level knowledge of statistical methodology in diagnostic medicine.
• Deep understanding of CLSI guidelines.
• Excellent written and verbal communication skills, including the ability to present to non-technical executive leadership.
• Demonstrated ability and enthusiasm for working on cross-functional teams with diverse technical backgrounds.
• Exceptional problem-solving skills and strong attention to detail.

Benefits:

• Competitive compensation with a remote USA pay range of $164,000 to $205,000 USD.
• Comprehensive medical, dental, vision, life, and disability coverage for eligible employees and dependents.
• Free testing for employees and their immediate families.
• Fertility care benefits.
• Pregnancy and baby bonding leave.
• 401(k) benefits.
• Commuter benefits.
• Employee referral program.

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