Unknown Company is hiring a Staff Non-Clinical Biostatistician (Biostatistician IV)

Exact Sciences is hiring a Staff Non-Clinical Biostatistician (Biostatistician IV) to apply strong statistical and computational expertise to the development, validation, and support of genomic biomarker assays. You will partner with thought leaders to design, analyze, and report on analytical validation and process monitoring studies.

What You'll Do

• Perform statistical activities to support experimental design, data analysis, process surveillance methods, study report preparation, and regulatory submissions.
• Represent statistics on product development project teams, providing strategic input on analytical validation study design and development plans.
• Exercise independent judgment to adapt statistical methods for unique project objectives.
• Mentor others within the organization on methods for analytical validation and process control.
• Partner with statistical collaborators and communicate effectively across all organizational levels.
• Work effectively within a multi-disciplinary team including scientists, pathologists, oncologists, and commercial, legal, and business development representatives.
• Independently lead complex research or development projects, influencing study design, analysis methods, and result interpretation.
• Prioritize tasks and drive results with a strong emphasis on quality.
• Support and comply with the company’s Quality Management System policies and procedures.
• Act with an inclusion mindset and model these behaviors for the organization.

What We're Looking For

• Ph.D. in Biostatistics, Statistics, or a related field or Master's degree in Biostatistics, Statistics, or related field plus 3 years of relevant work experience.
• 12+ years of relevant work experience in industry, academia, or a research institute.
• Demonstrated success using process control methods to surveille a complex multi-parameter process.
• Basic computer skills including Internet navigation, email, and word processing; proficiency 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.

Nice to Have

• Demonstrated statistical experience in analytical validation studies in molecular diagnostic, drug, or medical device development.
• Advanced knowledge of CLSI Guidelines.
• Professional knowledge analyzing genomic marker data.
• Experience developing products for approval by regulatory authorities such as the FDA.
• Professional knowledge working in oncology and clinical diagnostics.
• Professional knowledge working in a regulated industry (CLIA, FDA, or EU).

Technical Stack

• Statistical Programming: SAS, R, Python
• Productivity & Analysis: Microsoft Office
• Process Monitoring: Tableau or other “dashboard” software

Team & Environment

You will work within a multi-disciplinary team including scientists, pathologists, oncologists, and representatives from commercial, legal, and business development functions.

Benefits & Compensation

• Compensation range: $121,000.00 - $206,000.00
• Bonus eligibility
• Paid time off (including days for vacation, holidays, volunteering, and personal time)
• Paid leave for parents and caregivers
• Retirement savings plan
• Wellness support
• Health benefits including medical, prescription drug, dental, and vision coverage

Work Mode

This is a hybrid position based at Exact Sciences locations.

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.