About the Job:

The Biostatistician I is responsible for providing statistical and/or data science expertise and managing the activities for the development and validation of cancer diagnostic 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. The incumbent has opportunities to participate in translational or clinical research. This role builds and maintains strong collaboration with other teams across the organization to develop statistical models, write study protocols, perform statistical analysis, write study reports, provide responses to statistical issues arising from regulatory or external partners, represent FMI at regulatory agency (e.g. FDA) meetings, contribute to scientific publications, and/or work with internal and external partners (e.g., academic or Biopharma collaborators) for the development and approval of FMIs diagnostic assays.

We are a group of inquisitive biostatisticians and data scientists within the Research and Development team. We use our quantitative expertise to support the development, validation, and regulatory submission of FMIs comprehensive genomic tests; to generate clinical evidence for FMIs innovative assays by designing and executing statistical analysis plans; and to solve scientific problems by building novel statistical and machine learning models.

Key Responsibilities:

• Contribute to and execute the design and data analysis of analytical and clinical validation studies on novel next generation sequencing (NGS)-based cancer diagnostic tests, including but not limited to protocol development, statistical analysis plans, and data reporting.
• Support the development of innovative and creative statistical 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, 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 statistical quality standards and accuracy across all study deliverables while ensuring analyses are completed in accordance with established timelines.
• Maintain availability to the wider FMI business for statistical interpretation and analysis.
• Other duties as assigned.
• Comply with FMI's attendance policies

Qualifications:

Basic Qualifications:

• Masters Degree in Statistics, Biostatistics, Computational Biology or other quantitative fields and 2+ years of experience; OR
• PhD in Statistics, Biostatistics, Computational Biology or other quantitative fields
• Strong programming skills in R and Python

Preferred Qualifications:

• Doctor of Philosophy in Statistics, Biostatistics, Computational Biology or other quantitative fields.
• Work or internship experience as a biostatistician in biopharmaceutical or diagnostics industry, academia or FDA
• Knowledge and experience with machine learning and deep learning algorithms and packages
• Knowledge 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
• High level of detail orientation with a focus on quality
• Excellent communication, presentations and writing skills, and the ability to explain complex technical details in clear language
• 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 reflect FMIs values: Integrity, Courage, and Passion