Staff Non-Clinical Biostatistician (Biostatistician IV)

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At Exact Sciences, we're helpingchange how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.

Position Overview

The Staff Non-Clinical Biostatistician will hold strong statistical and computational skills to lead in the development, validation, and support of genomic assays. This role will directly partner with thought leaders in the design, analysis, reporting, and internal publication of reports pertaining to process monitoring and product development. This position requires in-depth understanding of methods of product development, reagent characterization, design of systems of assay control and approaches to maintenance of process control, and process troubleshooting.

This position is field based / remote.

Essential Duties

Include, but are not limited to, the following:

• 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 studies and the development plan.
• Contribute to establishing assay process control systems remotely, e.g., liaise with German staff (Trier lab) in utilization of process monitoring data, if necessary.
• Work on significant and unique issues. Exercise independent judgment in selecting and adapting methods appropriate for the specific objective.
• Use professional concepts and principles to achieve objectives in creative and effective ways.
• Mentor and support the activities within the organization for the development of methods of process control.
• Partner with statistical collaborators.
• Apply knowledge of theoretical and applied statistics.
• Apply strong statistical programming and analysis skills in industry standard analysis software, e.g., SAS, R, Python.
• Apply excellent oral, written, and presentation skills.
• Professional manner with the ability to communicate effectively throughout all levels of the organization.
• 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 interact with and exert significant influence on study design, analysis methods, and interpretation of study results, in consultation with a program team.
• Ability to prioritize and drive results with a strong emphasis on quality.
• Ability to integrate and apply feedback in a professional manner.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to lift up to 10 pounds for approximately 5% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 60% of a typical working day.
• Ability to spend 60% of a typical working day concentrating and or analyzing data.
• Ability to travel between Exact Sciences locations.
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Ph.D. in Biostatistics, Statistics, or field as outlined in the essential functions or Master's degree in Biostatistics, Statistics, or field as outlined in the essential functions and 3 years of relevant work experience in industry, academia, or a research institute in lieu of Ph.D.
• 12+ years of relevant work experience in industry, academia or a research institute.
• Demonstrated success in using process control methods to surveille a complex multi-parameter process and maintain nominal process function.
• Basic computer skills to include Internet navigation, Email usage, and word processing.
• Proficient in Microsoft Office.
• Familiarity with Tableau or other "dashboard" process monitoring software.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Professional knowledge analyzing genomic marker data.
• Professional knowledge working in oncology and clinical diagnostics.
• Professional knowledge working in the regulated industry (CLIA, FDA or EU).

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

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