Biostatistician with PhD

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 drive biostatistical strategy for evidence generation across diagnostics, clinical trials and real-world data (RWD/RWE) studies, 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.

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 drive biostatistical strategy for evidence generation across diagnostics, clinical trials and real-world data (RWD/RWE) studies, 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.

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

Maintain biostatistics quality standards, biostatistics best practices, and accuracy across all study deliverables while ensuring analyses are completed in accordance with established timelines

Maintain availability to the wider FMI business for biostatistical interpretation, analysis, and solutions

Master’s Degree in Statistics or Biostatistics and 4+ years of working experience; OR PhD in Statistics or Biostatistics with 2+ years of experience

Strong programming skills in R

D. in Statistics or Biostatistics with 2+ years of experience as a biostatistician in the biopharmaceutical or medical diagnostics industry, academia or government (e.g., Time-to event data analysis and longitudinal data analysis

Clinical and analytical validation of medical diagnostic devices and/or companion diagnostics

Categorical data analysis

Missing data analysis

Real-world data (RWD) analysis

Leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective cross-functional partnerships

Excellent communication, presentations and writing skills, and ability to explain complex technical details in clear language

Demonstrated ability to meet project deadlines managing multiple projects simultaneously

Demonstrated record of successful independent work and contributions to team projects

High level of detail orientation with a focus on quality

Understanding of HIPPA and importance of privacy of patient data

The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

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