Biostatistician II

About the Job The Biostatistician II is responsible for providing statistical and/or data science expertise and managing the activities for the development and validation of cancer diagnostic 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. The incumbent has opportunities to participate in translational or clinical research. The incumbent builds and maintains strong collaboration with other teams across the organization to develop statistical models, write study protocols, perform statistical analysis, write study reports, provide responses to statistical issues arising from regulatory or external partners, represent FMI at regulatory agency (e.g., FDA) meetings, contribute to scientific publications, and/or work with internal and external partners (e.g., academic or Biopharma collaborators) for the development and approval of FMI's diagnostic assays. Key Responsibilities Lead the design and data analysis of analytical and clinical validation studies on novel next generation sequencing (NGS)-based cancer diagnostic tests, including but not limited to protocol development, statistical analysis plans, and data reporting. Develop innovative and creative statistical and technical solutions to complex problems. Represent the biostatistics team within broad cross-functional projects. Collaborate with cross-functional teams on study design, planning, 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. Develop innovative and creative statistical and technical solutions to complex problems. Maintain statistical quality standards and accuracy across all study deliverables while ensuring analyses are completed in accordance with established timelines. Maintain availability to the wider FMI business for statistical interpretation and analysis. Other duties as assigned.

Qualifications:

Basic Qualifications:

Master's Degree in Statistics, Biostatistics or other quantitative fields and 4+ years of experience; OR PhD in Statistics, Biostatistics or other quantitative fields with 2+ years of experience Strong programming skills in

R Preferred Qualifications:

Doctor of Philosophy in Statistics, Biostatistics or other quantitative fields with 2+ years of experience as a biostatistician in biopharmaceutical or diagnostics industry, academia or FDA Experience in analytical validation of medical devices, time-to-event data analysis and longitudinal data analysis Proficiency in R. Experience with Python is desired Extensive scientific understanding of cancer genetics and genomics Knowledge with NGS and experience of genomic data analysis High level of detail orientation with a focus on quality Leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective partnerships Excellent communication, presentations and writing skills, and the ability to explain complex technical details in clear language Demonstrated ability to meet project deadlines Demonstrated record of successful independent work and contributions to team projects Understanding of HIPAA and the importance of patient data privacy Commitment to reflect FMI's values: Integrity, Courage, and Passion The expected salary range for this position based on the primary location of Boston, MA is $125,000 - $148,000 per year. The salary range is commensurate with Foundation Medicine's 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. #LI-Hybrid