Principal Biostatistician - Military veterans preferred

Foundation Medicine, Inc.

• Full Time

About the Job

The Principal Biostatistician 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 and timely delivery of data analyses, study reports and regulatory documents with high quality. 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 in regulatory or external partners. The function contributes to the long-term growth strategy of the Product Development team by participating in process improvement initiatives and contributing to the development of statistical methodologies applicable to companion diagnostic validation.

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.
• Represent the team within broad cross-functional projects and oversee multiple project teams.
• Mentor junior members on design and project deliverables.
• 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.
• 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.
• Manage team members.
• Travel domestically up to 10% of the time.
• Other duties as assigned.

Qualifications

Basic Qualifications

• Master’s Degree in Statistics or Biostatistics and 5+ years of experience as a statistician in academia or in the biopharmaceutical or diagnostics industry; OR,
• PhD in Statistics or Biostatistics and 3+ years of experience as a statistician in academia or in the biopharmaceutical or diagnostics industry

Preferred Qualifications

• PhD in Statistics or Biostatistics
• 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, random effect and measurement error models
• Experience in experimental study design
• Experience leading or managing a team of Biostatisticians
• Knowledge and experience with Next-Generation Sequencing (NGS)
• Extensive scientific understanding of cancer genetics and genomics
• Demonstrated history of independent thinking
• Demonstrated ability to meet project deadlines
• Demonstrated record of successful independent work and contributions to team projects
• Proficiency in statistical programming language R or SAS
• Demonstrated leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective partnerships
• Ability to work well under pressure while maintaining a professional demeanor
• Strong programming skills, technical proficiency and creativity
• Excellent communication, presentations and writing skills, and the ability to explain complex technical details in clear language
• High level of detail orientation with a focus on quality
• Understanding of HIPAA and importance of privacy of patient data.
• Commitment to FMI values: patients, innovation, collaboration, and passion.

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About Foundation Medicine

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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