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Principal Biostatistician

Full Time | Cambridge | Massachusetts | United States

About the Job

The Principal Biostatistician, Product Development is responsible for providing statistical expertise and managing the activities for personalized medicine companion diagnostic device analytical and clinical studies to ensure valid and efficient study designs that allow clearly interpretable results as well as timely, high quality delivery of data analyses, study reports and regulatory documents. The incumbent builds and maintains strong collaboration with other teams across the organization to develop study plans, study protocol, and decision framework as well as provide responses to statistical issues arising from regulatory or external partners. This role manage a small team of statisticians, and contributes to the long-term growth strategy of the Product Development Team by participating in development of statistical methodologies applicable to companion diagnostic validation and contributing to process improvement initiatives.

Key Responsibilities

• Lead the design and data analysis of analytical and clinical validation studies on novel next generation sequencing-based companion diagnostic devices for oncology.

• Provide key contributions to the analytical and clinical studies in the program, including but not limited to protocol development, statistical analysis plans, and data reporting.

• Contribute to the planning and delivery of key analytical or clinical components of regulatory submissions, including but not limited to Q-subs, PMA, and sPMA.

• Provide strategic contributions in addressing statistical issues from challenges to the company's products.

• Represent Biostatistics in key regulatory meetings.

• Develop innovative and creative statistical and technical solutions to complex problems.

• Maintain statistics quality standards throughout the study process and statistical accuracy in all documents pertaining to the study.

• Ensure statistical work is completed in accordance with established timeframes.

• Manage a small team of statisticians and provide direction, evaluation and hiring in the department as needed.

• Serve as a resource for less experienced Biostatisticians.

• Track biostatistics activity deliverables.

• Collaborate with laboratory scientists, technologists and the Regulatory team on study design, planning, data preparation, programming, analysis and presentation of results.

• Draft study protocols and issue final reports on these studies.

• Maintain availability to the wider FMI business for statistical interpretation and analysis.

• Solicit feedback and communicate study results within FMI and to external stakeholders.

• Other duties as assigned.

Qualifications

Basic Qualifications

• Master’s Degree in Bioinformatics, Statistics or a field with a significant quantitative focus

• 3+ years of experience in the biopharmaceutical or diagnostics industry in a statistically-oriented role

• Proficiency in statistical programming language R or SAS

Preferred Qualifications

• Doctor of Philosophy in Bioinformatics, Statistics or a field with a significant quantitative focus

• Extensive scientific understanding of cancer genetics and genomics

• Knowledge and experience with Next-Generation Sequencing (NGS)

• 5+ years of experience as a statistician in academia or in the biopharmaceutical or diagnostics industry

• Experience:

·   in time-to-event data analysis, cluster/longitudinal data analysis, and measurement error model

·   leading or managing a team of Biostatisticians

·   explaining complex technical details in clear language

• History of independent contributions, independent thought and successful independent work as well as collaborative contributions to team projects

• Demonstrated leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective partnerships

• High level of detail orientation with a focus on quality

• Strong programming skills, technical proficiency and creativity

• Strong verbal, writing, presentation, and communication skills Demonstrated ability to meet project deadlines and to work well under pressure while maintaining a professional demeanor

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to reflect FMI’s values: passion, patients, innovation, and collaboration

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Internal applicants, please use your FMI email address.

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