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About the Job:

The Sr Biostatistician is responsible for providing statistical and data science expertise and managing the activities for the development and validation of cancer diagnostic devices. The incumbent independently 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 applies the appropriate statistical and machine learning methods to solve complex scientific problems. In addition, the incumbent builds and maintains strong collaboration with other teams across the organization and serves as the statistical expert in cross-functional collaborations. The incumbent has opportunities to 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 FMIs diagnostic assays.

We are a group of inquisitive biostatisticians and data scientists within the Research and Development team. We use our quantitative expertise to support the development, validation, and regulatory submission of FMIs comprehensive genomic tests; to generate clinical evidence for FMIs innovative assays by designing and executing statistical analysis plans; and to solve scientific problems by building novel statistical and machine learning models.

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 or apply innovative and creative statistical and computational solutions to complex problems.
• Collaborate with cross-functional teams as the biostatistics representative 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.
• 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.
• Mentor or supervise junior team members.
• Other duties as assigned .
• Comply with FMI's attendance policies

Qualifications:

Basic Qualifications:

• Masters Degree in Statistics, Biostatistics or other quantitative fields and 6+ years of experience; OR PhD in Statistics, Biostatistics or other quantitative fields with 4+ years of experience
• Strong programming skills in R

Preferred Qualifications:

• Doctor of Philosophy in Statistics, Biostatistics or other quantitative fields with 4+ years of experience as a biostatistician in biopharmaceutical or diagnostics industry, academia or FDA
• Extensive understanding and experience of common statistical methods in assay validation and/or computational methods in translational research
• Proficiency in R. Experience with Python is desired
• Extensive scientific understanding of cancer biology and NGS technology
• Leadership skills including mentoring junior team members, 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 with high-quality work
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMIs values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Boston, MA is $145,000 - $179,000 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.

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