Biostatistician I
About The Position
The Biostatistician I provides statistical and/or data science expertise and manages activities involved in the development and validation of cancer diagnostic devices. The role ensures valid, efficient study designs that produce clearly interpretable results, and supports timely delivery of high-quality data analyses, study reports, and regulatory documents. The position may also participate in translational or clinical research. Working within the Research and Development team, the Biostatistician I collaborates across the organization to develop statistical models, write study protocols, perform analyses, prepare study reports, address statistical questions from regulatory or external partners, and contribute to regulatory meetings and scientific publications. The role may also involve working with internal and external partners to support the development and approval of Foundation Medicine diagnostic assays.
Requirements
- Master's degree in Statistics, Biostatistics, Computational Biology, or another quantitative field and at least 2 years of experience; or a Ph.D. in one of these fields.
- Strong programming skills in R and Python.
- High attention to detail and focus on quality.
- Excellent communication, presentation, and writing skills, including the ability to explain complex technical details clearly.
- Demonstrated ability to meet project deadlines.
- Demonstrated record of successful independent work and contributions to team projects.
- Understanding of HIPAA and the importance of patient data privacy.
- Commitment to Foundation Medicine's values of Integrity, Courage, and Passion.
Nice To Haves
- Doctor of Philosophy in Statistics, Biostatistics, Computational Biology, or another quantitative field.
- Work or internship experience as a biostatistician in the biopharmaceutical or diagnostics industry, academia, or the FDA.
- Knowledge of and experience with machine learning and deep learning algorithms and packages.
- Knowledge of and experience with NGS, cancer genomics, and genomic data analysis.
- Experience in analytical validation of medical devices, time-to-event data analysis, and longitudinal data analysis.
Responsibilities
- Contribute to and execute the design and data analysis of analytical and clinical validation studies for novel next-generation sequencing (NGS)-based cancer diagnostic tests, including protocol development, statistical analysis plans, and data reporting.
- Support the development of innovative statistical and technical solutions to complex problems.
- Represent the biostatistics team, with guidance from senior team members, in broad cross-functional projects.
- Collaborate with cross-functional teams on study design, planning, data preparation, programming, analysis, and presentation of results.
- Contribute to planning and delivery of analytical or clinical components of regulatory submissions, and respond to review questions with guidance from senior team members.
- Maintain statistical quality standards and accuracy across study deliverables while completing analyses within established timelines.
- Provide statistical interpretation and analysis to the wider Foundation Medicine business.
- Comply with Foundation Medicine's attendance policies.
- Perform other duties as assigned.
Benefits
- Foundation Medicine benefits
- A discretionary annual bonus may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
