About the Job:
The Biostatistician I is responsible for providing statistical expertise and
managing the activities for the development, clinical and analytical validation,
and regulatory approval of FMI’s diagnostic devices including but not limited to
companion diagnostic (CDx) devices. 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. This
role builds and maintains strong collaborations with other departments across
the organization to develop statistical methodologies and models, write study
protocols, conduct statistical analyses, write study reports, present responses
to statistical and study design questions arising from regulatory authorities or
external partners (e.g., academic or Biopharma collaborators), represent FMI at
meetings with regulatory agencies such as the Food and Drug Administration,
contribute to scientific publications, and/or work with internal and external
partners for the development, validation, and regulatory approval of FMI’s
diagnostic assays in oncology and beyond.
Key Responsibilities:
Contribute to and execute the design and data analysis of analytical and
clinical validation studies on novel next generation sequencing (NGS)-based
diagnostic devices for oncology and beyond, including but not limited to
protocol development, statistical analysis plans and reports, and data
reporting.
Support the development of innovative and creative biostatistical and
technical solutions to complex problems.
Represent the biostatistics team with guidance from senior team members
within broad cross-functional projects.
Collaborate with cross-functional teams on study design, planning, strategy,
data preparation, programming, analysis, and presentation of results.
Contribute to the planning and delivery of key analytical or clinical
components of regulatory submissions and respond to review questions with
guidance from senior team members.
Maintain biostatistics quality standards, biostatistics best practices, and
accuracy across all study deliverables while ensuring analyses are completed
in accordance with established timelines.
Maintain availability to the wider FMI business for biostatistical
interpretation, analysis, and solutions.
Other duties as assigned.
Comply with FMI's attendance policies
Qualifications:
Basic Qualifications:
Master’s Degree in Statistics or Biostatistics and 2+ years of working
experience; OR PhD in Statistics or Biostatistics.
Strong programming skills in R
Preferred Qualifications:
Ph.D. in Statistics or Biostatistics
Work or internship experience as a biostatistician in the biopharmaceutical
or medical diagnostics industry, academia or government (e.g., FDA, NIH)
Knowledge and experience with one or more of the following:
Clinical Study Design
Clinical Trials
Time-to event data analysis and longitudinal data analysis
Statistical Methods in Diagnostic Medicine
Clinical and analytical validation of medical diagnostic devices and/or
companion diagnostics
Categorical data analysis
Missing data analysis
Real-world data (RWD) analysis
Bayesian Methods
Next Generation Sequencing (NGS) and genomics
Excellent communication, presentations and writing skills, and ability to
explain complex technical details in clear language
Demonstrated ability of independent thinking
Demonstrated ability to meet project deadlines managing multiple projects
simultaneously
Strong interpersonal skills including collaboration and problem solving with
cross functional departments and colleagues
Demonstrated record of successful independent work and contributions to team
projects
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: Integrity, Courage, and Passion
The expected salary range for this position based on the primary location of
Remote is $103,700 - $124,000 per year. The salary range is commensurate with
Foundation Medicines compensation practice and considers factors including, but
not limited to, education, training, experience, external market conditions,
criticality of role, and internal equity. A discretionary annual bonus may be
available based on individual and Company performance. This position also
qualifies for Foundation Medicine's benefits.
#LI-Remote