Lead Biostatistician (Analytical Validation)

Posted 28 days agoViewed

💎 Seniority level: Lead, 6+ years

📍 Location: USA

💸 Salary: 126000.0 - 157500.0 USD per year

🔍 Industry: Biotechnology

🏢 Company: Natera👥 1001-5000💰 $250,000,000 Post-IPO Equity over 1 year ago🫂 Last layoff about 2 years agoWomen's Biotechnology Medical Genetics Health Diagnostics

⏳ Experience: 6+ years

🪄 Skills: Project ManagementData AnalysisCross-functional Team LeadershipCommunication SkillsAnalytical SkillsProblem SolvingAgile methodologiesWritingData visualizationData management

Requirements:

Minimum 6 years of relevant industry experience, with a focus on analytical validation in diagnostics, biotechnology, or related industries.
Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.
Expert working knowledge of statistical methodology in diagnostic medicine, including an understanding of CLSI and FDA guidelines
Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
Strong track record of producing high quality written documentation for multiple audiences.
Exceptional problem-solving skills and attention to detail

Responsibilities:

Oversee the design, statistical analysis, and interpretation of analytical validation studies in support of oncology product development.
Partner with bench scientists, regulatory, and product development teams to integrate statistical expertise into project planning and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary teams.
Prepare high-quality protocols and reports for cross-functional collaborators and stakeholders.
Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA, NYS, and the FDA.
Provide leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity.

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