Biostatistician II

Foundation Medicine

11d•Onsite

About The Position

The Biostatistician II 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 drive biostatistical strategy for evidence generation across diagnostics, clinical trials and real-world data (RWD/RWE) studies, 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.

Requirements

Master’s Degree in Statistics or Biostatistics and 4+ years of working experience; OR PhD in Statistics or Biostatistics with 2+ years of experience
Strong programming skills in R

Nice To Haves

Ph.D. in Statistics or Biostatistics with 2+ years of 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
Leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective cross-functional partnerships
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
Demonstrated record of successful independent work and contributions to team projects
High level of detail orientation with a focus on quality
Understanding of HIPPA and importance of privacy of patient data
Commitment to reflect FMI’s values: Integrity, Courage, and Passion

Responsibilities

Lead 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
Develop 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