Exact Sciences is looking to change how the world prevents, detects and guides treatment for cancer by providing clarity to patients and clinicians for confident decision-making. The Staff Non-Clinical Biostatistician will support the development, validation, and support of genomic biomarker assays, partnering with thought leaders in the design, analysis, reporting, and internal publication of reports pertaining to analytical validation and process monitoring.
Requirements
- Apply strong statistical and computational skills to participate in the development, validation, and support of genomic biomarker assays.
- In-depth understanding of methods of analytical validation and process control.
- Apply strong statistical programming and analysis skills in industry standard analysis software, e.g., SAS, R, Python.
- Demonstrated success in using process control methods to surveille a complex multi-parameter process and maintain nominal process function.
- Familiarity with Tableau or other “dashboard” process monitoring software.
- Demonstrated statistical experience in analytical validation studies in molecular diagnostic, drug, or medical device development.
- Professional knowledge analyzing genomic marker data.
Responsibilities
- Perform statistical activities in support of development of experimental and study design and protocol, data analysis, methods of process surveillance, preparation of study reports, serve as subject matter expert in service of regulatory submissions, and liaise with departments throughout Exact.
- Represent the statistics function on project teams for product development programs, providing strategic input and contributing significantly to the design of analytical validation studies and the development plan.
- Mentor and support the activities within the organization for the development of methods of analytical validation and process control.
- Apply knowledge of theoretical and applied statistics.
- Apply strong statistical programming and analysis skills in industry standard analysis software, e.g., SAS, R, Python.
- Ability to interact with and exert significant influence on study design, analysis methods, and interpretation of study results, in consultation with a program team.
- Support and comply with the company’s Quality Management System policies and procedures.
Other
- Ability to work effectively in a multi-disciplinary team including scientists, pathologists, oncologists, and representatives from commercial, legal, and business development functions.
- Ability to independently lead complex research or development projects requiring an understanding of scientific principles and concepts, as well as relevant developments in the field (including peer-reviewed internal or external presentations or publications) that demonstrate expertise in the field.
- Ability to prioritize and drive results with a strong emphasis on quality.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
