Director of Biostatistics (R&D)
Core
Lead a biostatistics team to design, analyze, and interpret analytical validation studies for oncology molecular tests, ensuring regulatory compliance and driving data-informed decisions.
Role type
Director of Biostatistics (R&D)
Builds
Oncology molecular tests and diagnostic devices
Domain
Oncology / Diagnostics / Biostatistics
Deliverable
production ML models | dashboards & analysis
Required skills
Statistical methodology, study design, regulatory compliance (FDA/CAP/CLIA), team leadership, cross-functional collaboration, technical documentation, strategic planning
Preferred skills
NGS, genetics, oncology domain expertise, prior FDA interaction experience
Technologies
NGS, genetics
Responsibilities
Build and mentor a high-performing biostatistics team; oversee design and analysis of analytical validation studies; partner with bench scientists and regulatory teams; prepare protocols and reports for stakeholders; ensure statistical methodologies meet regulatory standards; lead statistical interactions with regulatory agencies; drive innovation in statistical methods.
Seniority
Director, strategic leadership & team management