About the Job

The Biostatistician, Product Development is responsible for leading data analysis and supporting analytical and clinical validation design and study protocols for companion diagnostic assays, performing statistical analyses, and writing study reports for novel biomarker development and oncology companion diagnostic programs.

Key Responsibilities

• Design and analyze 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 study protocol development, statistical analysis plans, and data reporting.
• Provide key contributions to the planning and delivery of key analytical or clinical components of regulatory submissions including but not limited to Q-subs, PMA, and sPMA.
• Communicate with FDA on analytical and clinical study design and data analysis plans for regulatory approval or clearance of oncology companion diagnostic assays.
• Contribute to drafting study protocols and final reports, soliciting feedback, communicating study results within FMI and to external stakeholders.
• Collaborate with laboratory scientists and technologists and Regulatory Affairs team on study design, planning, data preparation, programming, analysis and presentation of results.
• Other duties as assigned.

Qualifications

Basic Qualifications

• Master’s Degree in Statistics or Biostatistics
• Fluency in one or more computing software languages related to statistics or biostatistics

Preferred Qualifications

• Ph.D. in Statistics or Biostatistics
• 2+ years of working experience as a statistician in academia or in the biopharmaceutical, diagnostics, or life sciences industry
• Knowledge and experience with Next Generation Sequencing (NGS) 
• Experience in working with biopharmaceutical companies for CDx development
• Strong proficiency in computer programming languages such as R or SAS
• Demonstrated history of independent thinking
• Demonstrated ability to meet project deadlines
• Demonstrated record of successful independent work and contributions to team projects
• Extensive scientific understanding of cancer genetics and genomics
• Technical proficiency and creativity
• Ability to explain complex technical details in clear language
• Strong interpersonal skills that include excellent skills in written and oral communication, presentation skills, collaboration, and problem solving with other departments and colleagues
• High level of detail orientation with a focus on quality
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI’s values: passion, patients, collaboration, and innovation.

#LI-Hybrid