Biostatistician I
About The Position
The Biostatistician I provides statistical and data science expertise and manages activities supporting 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 collaboratively with teams across Foundation Medicine, the Biostatistician I helps develop statistical models, write study protocols and reports, perform statistical analyses, address statistical questions from regulators and external partners, represent the company at regulatory agency meetings, and contribute to scientific publications. The role also supports internal and external collaborations related to the development and approval of diagnostic assays. Within the Research and Development team, the position supports development, validation, and regulatory submission of genomic tests, generates clinical evidence through statistical analysis plans, and helps solve scientific problems using statistical and machine-learning models.
Requirements
- Master’s degree in Statistics, Biostatistics, Computational Biology, or another quantitative field and at least 2 years of experience, or a PhD in one of these or another quantitative field.
- Strong programming skills in R and Python.
Nice To Haves
- PhD in Statistics, Biostatistics, Computational Biology, or another quantitative field.
- Work or internship experience as a biostatistician in the biopharmaceutical or diagnostics industry, academia, or FDA.
- Knowledge of and experience with machine-learning and deep-learning algorithms and packages.
- Knowledge of and experience with next-generation sequencing, cancer genomics, and genomic data analysis.
- Experience in analytical validation of medical devices, time-to-event data analysis, and longitudinal data analysis.
- Strong 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 ability to work independently and contribute to team projects.
- Understanding of HIPAA and the importance of patient data privacy.
- Commitment to Foundation Medicine’s values of Integrity, Courage, and Passion.
Responsibilities
- Contribute to and execute the design and data analysis of analytical and clinical validation studies for novel next-generation sequencing-based cancer diagnostic tests, including protocol development, statistical analysis plans, and data reporting.
- Support development of innovative statistical and technical solutions to complex problems.
- Represent the biostatistics team within broad cross-functional projects, with guidance from senior team members.
- 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 and ensure analyses are completed within established timelines.
- Remain available to the wider business for statistical interpretation and analysis.
- Perform other duties as assigned.
- Comply with FMI's attendance policies.
Benefits
- Eligibility for 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
