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Biostatistician

Cambridge | Massachusetts | United States

 

ABOUT FOUNDATION MEDICINE:

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives. 

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 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 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 in 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 team on study design, planning, data preparation, programming, analysis and presentation of results.
  • Other duties as assigned.

 

QUALIFICATIONS
Basic Qualifications:

 

Preferred Qualifications:

  • Ph.D. in Statistics or Biostatistics
  • 2+ years of working experience as a statistician in academia or life sciences industry
  • Experience in NGS based Companion Product Diagnostic (CDx) development for both tissue and liquid
  • Experience in regulatory submission process with authorities (such as CDRH/FDA in the U.S. and PMDA in Japan)
  • Experience in working with biopharmaceutical companies for CDx development
  • Strong proficiency in computer programming languages such as R or SAS
  • Ability to explain complex technical details in clear language
  • Extensive scientific understanding of cancer genetics and genomics
  • Technical proficiency and creativity
  • Demonstrated history of independent thinking
  • Demonstrated ability to meet project deadlines
  • Strong interpersonal skills that include excellent skills in written and oral communication, presentation skills, collaboration, and problem solving.
  • Demonstrated record of successful independent work and contributions to team projects
  • High level of detail orientation with a focus on quality
  • Commitment to reflect FMI’s values: passion, patients, collaboration, and innovation

 

Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

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