Senior Biostatistician
Apply NowCompany: Foundation Medicine
Location: Boston, MA 02115
Description:
Job Description
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.
#LI-Hybrid
About Us
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.
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)
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.
#LI-Hybrid
About Us
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.
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)