Biostatistician II

Biostatistician IIThe 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.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 reportingDevelop innovative and creative biostatistical and technical solutions to complex problemsRepresent the biostatistics team with guidance from senior team members within broad cross-functional projectsCollaborate with cross-functional teams on study design, planning, strategy, data preparation, programming, analysis, and presentation of resultsContribute to the planning and delivery of key analytical or clinical components of regulatory submissions and respond to review questions with guidance from senior team membersMaintain biostatistics quality standards, biostatistics best practices, and accuracy across all study deliverables while ensuring analyses are completed in accordance with established timelinesMaintain availability to the wider FMI business for biostatistical interpretation, analysis, and solutionsOther duties as assignedQualifications:Basic Qualifications:Master's Degree in Statistics or Biostatistics and 4+ years of working experience; OR PhD in Statistics or Biostatistics with 2+ years of experienceStrong programming skills in RPreferred Qualifications:Ph.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., FDA, NIH)Knowledge and experience with one or more of the following: Clinical Study DesignClinical TrialsTime-to event data analysis and longitudinal data analysisStatistical Methods in Diagnostic MedicineClinical and analytical validation of medical diagnostic devices and/or companion diagnosticsCategorical data analysisMissing data analysisReal-world data (RWD) analysisBayesian MethodsNext Generation Sequencing (NGS) and genomicsLeadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective cross-functional partnershipsExcellent communication, presentations and writing skills, and ability to explain complex technical details in clear languageDemonstrated ability of independent thinkingDemonstrated ability to meet project deadlines managing multiple projects simultaneouslyDemonstrated record of successful independent work and contributions to team projectsHigh level of detail orientation with a focus on qualityUnderstanding of HIPPA and importance of privacy of patient dataCommitment to reflect FMI's values: Integrity, Courage, and PassionThe expected salary range for this position based on the primary location of Boston, MA is $125,000 - $156,300 per year. 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.