Senior Biostatistician

About The Job

The Senior Biostatistician is responsible for independently 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 independently

mentors 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 Scientific Operations team by participating in process improvement initiatives and contributing to

the development of statistical methodologies applicable to companion diagnostic validation.

Key Responsibilities

• Lead independently 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.
• Independently 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 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.
  
  

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, or FDA

• Experience in time-to-event data analysis, cluster/longitudinal data analysis, clinical trials, random
  
  

effect and measurement error models

• Experience in experimental study design and statistical methods in diagnostic medicine
• 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.