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Position Overview

The Clinical Biostatistician collaborates with interdisciplinary, cross-functional teams to develop and establish evidence for molecular tests for screening, diagnosis, prognosis, monitoring, and therapy selection in oncology.

This position is remote.

Essential Duties

Include, but are not limited to, the following:

• Under the direction of other statisticians, assist the biostatistical function on project-level work.
• Provide input into the design of analytical validity, clinical validity, clinical utility, health economics, and clinical experience studies by:
  • Evaluating evidentiary requirements.
  • Contributing to proposals, FDA pre-submissions, and study protocols (selecting endpoints, power and sample size calculations, and analysis plans).
  • Reviewing case report forms and data transfer requirements.
  • Drafting statistical analysis plans.
• Apply standard statistical methodology and programming to:
  • Monitor laboratory and clinical data quality.
  • Develop evidence for clinical predictive models in clinical studies and trials.
  • Conduct simulation studies.
• Communicate statistical results in tables, figures, and listings; statistical analysis reports; clinical study reports; abstracts; manuscripts; regulatory submissions; presentations; and marketing collateral.
• Evaluate investigator sponsored study designs and analysis plans, evidence developed for external molecular tests, and applicability of novel statistical techniques.
• Ability to apply strong verbal, written, and graphical communication/presentation skills.
• Ability to regularly seek and integrate feedback from team members and managers in a professional manner.
• Ability to work independently, prioritizing and producing high quality results.
• Ability to collaborate effectively as part of a cross-functional team.
• 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 work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to travel up to 5% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Master's degree in Biostatistics or related field as outlined in the essential duties.
• Working knowledge of theoretical and applied statistics.
• Strong statistical programming skills (SAS, R, or Python).
• Basic computer skills to include internet navigation and email usage.
• Working knowledge of Microsoft Office programs, such as Word, Excel, PowerPoint, Outlook, Access, OneNote, and Publisher.
• 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

• 2 years of relevant work experience.
• Experience in molecular diagnostic, drug, or medical device development; epidemiology; public health; or healthcare.
• Experience in developing products for approval by regulatory authorities such as FDA.

Salary Range:

National Ranges: $71, 000 - $117,000

California Ranges: $86,400.00- $129,600.00

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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