Biostatistician II

About this role

About the Job The Biostatistician II is responsible for providing statistical expertise and managing the activities for the development, clinical and analytical validation, and regulatory approval of FMI’s diagnostic devices including but not limited to companion diagnostic (CDx) devices. The incumbent ensures valid and efficient study designs that allow clearly interpretable results and timely delivery of data analyses, study reports and regulatory documents with high quality. This role builds and maintains strong collaborations with other departments across the organization to develop statistical methodologies and models, write study protocols, conduct statistical analyses, write study reports, present responses to statistical and study design questions arising from regulatory authorities or external partners (e.g., academic or Biopharma collaborators), represent FMI at meetings with regulatory agencies such as the Food and Drug Administration, contribute to scientific publications, and/or work with internal and external partners for the development, validation, and regulatory approval of FMI’s diagnostic assays in oncology and beyond

Key Responsibilities Lead and execute the design and data analysis of analytical and clinical validation studies on novel next generation sequencing (NGS)-based diagnostic devices for oncology and beyond, including but not limited to protocol development, statistical analysis plans and reports, and data reporting. Develop innovative and creative biostatistical and technical solutions to complex problems. Represent the biostatistics team with guidance from senior team members within broad cross-functional projects

Collaborate with cross-functional teams on study design, planning, strategy, data preparation, programming, analysis, and presentation of results. Contribute to the planning and delivery of key analytical or clinical components of regulatory submissions and respond to review questions with guidance from senior team members

Apply for this role on Foundation Medicine’s official careers site.