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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 II

  • Remote, Massachusetts, United States
  • Full Time

About the Job

The Biostatistician II is responsible for providing statistical and/or data science expertise and managing the activities for the development and validation of cancer diagnostic device.  The incumbent 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 has opportunities to participate in translational or clinical research. The incumbent builds and maintains strong collaboration with other teams across the organization to develop statistical models, write study protocols, perform statistical analysis, write study report, provide responses to statistical issues arising in regulatory or external partners, represent FMI at regulatory agency (FDA, PMDA) meetings, contribute to scientific publications, and/or work with internal and external partners (e.g. academic or Biopharma collaborators) for the development and approval of FMI’s diagnostic assays. 

We are a group of inquisitive biostatisticians and bioinformaticians within the product development team. We use our quantitative expertise to support the development, validation, and regulatory submission of FMI’s comprehensive genomic tests; to generate clinical evidence for FMI’s innovative assays by designing and executing statistical analysis plans; and to solve scientific problems by building novel statistical and machine learning models. 

 We work at the intersection of biostatistics and genomics so the ideal candidate can either be a biostatistician with a deep understanding of statistical methods such as sample size estimation and survival analysis, or a biomedical data scientist with experience of applying statistical or machine learning models to genomics data.

 

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, Biostatistics, Data Science, Bioinformatics, or Computational Biology plus 2+ years of as a statistician or biomedical data scientist in academia or in the biopharmaceutical or diagnostics industry, or FDA

OR

  • PhD in Statistics, Biostatistics, Data Science, Bioinformatics, Computational Biology.

 

  • Proficiency in statistical programming language R or SAS.

Preferred Qualifications

  • Doctor of Philosophy in Statistics, Biostatistics, Data Science, Bioinformatics, Computational Biology.
  • 1+ years 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 leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective partnerships.
  • Strong programming skills, technical proficiency and creativity.
  • Excellent communication, presentations and writing skills, and the ability to explain complex technical details in clear language.
  • Demonstrated ability to meet project deadlines.
  • Demonstrated record of successful independent work and contributions to team projects.
  • 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.

 

 

 

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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