[Remote] Biostatistician

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Note: The job is a remote job and is open to candidates in USA. Foundation Medicine is a leader in precision medicine solutions, and they are seeking a Biostatistician to lead data analysis and support analytical and clinical validation design for companion diagnostic assays. The role involves designing studies, performing statistical analyses, and collaborating with various teams to ensure successful regulatory submissions for oncology diagnostics.


Responsibilities

  • Design and analyze analytical and clinical validation studies on novel next generation sequencing-based companion diagnostic devices for oncology.
  • Provide key contributions to the analytical and clinical studies in the program, including but not limited to study protocol development, statistical analysis plans, and data reporting.
  • Provide key contributions to the planning and delivery of key analytical or clinical components of regulatory submissions including but not limited to Q-subs, PMA, and sPMA.
  • Communicate with FDA on analytical and clinical study design and data analysis plans for regulatory approval or clearance of oncology companion diagnostic assays.
  • Contribute in drafting study protocols and final reports, soliciting feedback, communicating study results within FMI and to external stakeholders.
  • Collaborate with laboratory scientists and technologists and Regulatory Affairs team on study design, planning, data preparation, programming, analysis and presentation of results.
  • Other duties as assigned.

Skills

  • Master’s Degree in Statistics or Biostatistics
  • Fluency in one or more computing software languages related to statistics or biostatistics
  • Ph.D. in Statistics or Biostatistics
  • 2+ years of working experience as a statistician in academia, the biopharmaceutical, diagnostics, or life sciences industry
  • Knowledge and experience with Next Generation Sequencing (NGS)
  • Experience in regulatory submission process with authorities (such as CDRH/FDA in the U.S. and PMDA in Japan)
  • Experience in working with biopharmaceutical companies for CDx development
  • Strong proficiency in computer programming languages such as R or SAS
  • Excellent communication, presentations and writing skills, and the ability to explain complex technical details in clear language
  • Extensive scientific understanding of cancer genetics and genomics
  • Technical proficiency and creativity
  • Demonstrated history of independent thinking
  • Demonstrated ability to meet project deadlines
  • Strong interpersonal skills that include excellent skills in written and oral communication, presentation skills, collaboration, and problem solving with other departments and colleagues
  • Demonstrated record of successful independent work and contributions to team projects
  • High level of detail orientation with a focus on quality

Benefits

  • A discretionary annual bonus may be available based on individual and Company performance.
  • This position also qualifies for FMI benefits.

Company Overview

  • Foundation medicine is a molecular information company developing clinical diagnostic tests that facilitates personalized cancer therapies. It was founded in 2010, and is headquartered in Cambridge, Massachusetts, USA, with a workforce of 1001-5000 employees. Its website is

    • Company H1B Sponsorship

  • Foundation Medicine has a track record of offering H1B sponsorships, with 15 in 2025, 41 in 2024, 30 in 2023, 36 in 2022, 41 in 2021, 45 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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