Director of Biostatistics (R&D)

PRIMARY RESPONSIBILITIES

• Team Leadership: Build, mentor, and direct a high-performing biostatistics team, fostering collaboration, and overseeing their technical and professional development.
• Study Design and Analysis: Oversee the design, statistical analysis, and interpretation of analytical validation studies in support of oncology product development.
• Cross-Functional Collaboration: 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.
• Documentation and Reporting: Prepare high-quality protocols and reports for cross-functional internal and external collaborators and stakeholders.
• Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA and the FDA. Lead statistical interactions with regulatory agencies.
• Innovation and Improvement: Provide leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity.
• Strategic Leadership: Continuously improve the efficiency and efficacy of the team through innovative techniques and strategies. Promote departmental standards for the development and execution of statistical analyses, ensuring alignment with company goals and regulatory requirements.

QUALIFICATIONS

• Minimum of 8 years of industry experience, including at least 5 years experience in diagnostics. Experience with NGS, genetics, and oncology preferred.
• At least 5 years experience leading a team.
• Master’s degree in statistics, biostatistics, or equivalent, PhD preferred.

KNOWLEDGE, SKILLS, AND ABILITIES

• Aptitude for technical leadership and strategic thinking
• Proven record of leading a successful team
• Expert working knowledge of statistical methodology in diagnostic devices, including FDA guidelines.
• Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds.