About the Job

The Senior 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 mentors or supervises junior staff; 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 or supervise 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.
• 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.
• 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 Statistics (or Biostatistics) and 3+ years of experience as a statistician in academia, biopharmaceutical, or diagnostics industry, academia, or FDA; OR,
• PhD in Statistics (or Biostatistics) and 1+ year(s) of experience as a statistician in academia or in the biopharmaceutical or diagnostics industry, academia, or FDA
• Proficiency in statistical programming language R or SAS

Preferred Qualifications

• Doctor of Philosophy in Biostatistics or Statistics
• 3+ 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
• Extensive scientific understanding of cancer genetics and genomics
• Knowledge and experience with Next-Generation Sequencing (NGS)
• Experience leading or managing a team of Biostatisticians
• Demonstrated leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective partnerships
• Strong programming skills, technical proficiency and creativity
• Demonstrated history of independent thinking
• Demonstrated ability to meet project deadlines
• Demonstrated record of successful independent work and contributions to team projects
• 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
• Ability to work well under pressure while maintaining a professional demeanor
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion.

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