About the Job

The Biostatistician II is responsible for providing statistical expertise and managing the activities for personalized medicine companion diagnostic device analytical and clinical studies. This position 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 builds and maintains strong collaboration with other teams across the organization to develop study plans, study protocol as well as perform statistical analysis, write study reports, provide responses to statistical issues arising in regulatory or external partners, represent FMI at regulatory agency (FDA, PMDA) meetings, and/or work with internal and external partners (e.g. Biopharma) 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-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.
• Represent Biostatistics in internal submission /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.
• 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.
• Other duties as assigned.

Qualifications:

Basic Qualifications:

• Master’s Degree in Statistics (or Biostatistics)
• 2+ years of experience as a statistician in academia or in the biopharmaceutical or diagnostics industry, academia, or FDA or PhD in Statistics (or Biostatistics)
• Proficiency in statistical programming language R or SAS

Preferred Qualifications:

• Doctor of Philosophy in Biostatistics or Statistics
• 1+ year(s) 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 ability to meet project deadlines
• Demonstrated record of successful independent work and contributions to team projects
• 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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