Person, Text, Face


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

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Biostatistician II is responsible for providing statistical expertise and managing the activities for personalized medicine companion diagnostic device analytical and clinical studies. This position 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 builds and maintains strong collaboration with other teams across the organization to develop study plans, study protocol as well as perform statistical analysis, write study reports, provide responses to statistical issues arising in regulatory or external partners, represent FMI at regulatory agency (FDA, PMDA) meetings, and/or work with internal and external partners (e.g. Biopharma) for the development and approval of FMI’s diagnostic assays.

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.


Basic Qualifications

• Master’s Degree in Statistics (or Biostatistics)

• 2+ years of experience as a statistician in academia or in the biopharmaceutical or diagnostics industry, academia, or FDA or PhD in Statistics (or Biostatistics)

• Proficiency in statistical programming language R or SAS

Preferred Qualifications

• Doctor of Philosophy in Biostatistics or Statistics

• 1+ year(s) 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 ability to meet project deadlines

• Demonstrated record of successful independent work and contributions to team projects

• Demonstrated leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective partnerships

• Ability to work well under pressure while maintaining a professional demeanor

• Strong programming skills, technical proficiency, and creativity

• 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

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion


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.

Apply Now

Internal applicants, please use your FMI email address.

Please let me know about more jobs like this

Not You?

Thank you

Recommended Jobs

Molecular Technologist II

Lab Operations 101238 Penzberg, Bavaria DE Germany Penzberg, Bavaria DE, Germany, 82377 Operations
Position Summary The Molecular Technologist II is responsible for performing all aspects of complex patient sample testing, such as solution and reagent preparation, equipment maintenance, and tasks that pertain to the handling and testing of pa...

Director, Clinical Development Product Lead

Clinical Development and Decision Science 101263 Boston Massachusetts United States Seaport Blvd., Boston, Massachusetts, United States Medical
About the Job The Director, Clinical Development is a highly visible and cross-functional leadership role on the Foundation Medicine (FMI) Clinical Development team. This individual serves as Clinical Lead for one of the products within the portf...

Molecular Technician

Lab Operations 101295 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States Operations
About the Job The Molecular Technician is responsible for solution and reagent preparation, equipment maintenance, monitoring and tracking equipment and run cycle times, maintaining materials stocks in the labs, organizing process document manage...

Senior Experience Designer

Engineering 101300 Boston Massachusetts United States United States. Seaport Blvd., Boston, Massachusetts, United States Technology
About the Job The Senior Experience Designer acts as a strong voice for the user and can prioritize business goals to arrive at high-value design solutions. In many cases, the individual in this role is called on to explain concepts to scientists...

Send to a friend

Not You?

Thank you for sending this job to your friend.

Clothing, Apparel, Person, Scarf, Finger, Plant, Sitting, Female
Lab, Apparel, Clothing, Person, Scientist, Coat, Lab Coat

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)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.