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The Research and Development team at Foundation Medicine is constantly pushing the envelope to transform cancer care.

Watch the video above to see how each member has the chance to make a real impact. 

 

Biostatistician

  • Cambridge, Massachusetts, United States
  • Full Time

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

 

 

 

Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

 

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.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Internal applicants, please use your FMI email address.

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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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