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

Essential Duties

• Independently and effectively represents the biostatistical function for a product, providing strategic input and contributing significantly to objectives in creative ways.
• Designs and advises the design of 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
  • Authoring and reviewing statistical analysis plans
• Applies complex statistical methodology and programming to:
  • Monitor clinical data quality
  • Develop evidence for clinical predictive models in clinical studies and trials
  • Conduct simulation studies
• Communicates 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.

Minimum Qualifications

• Master's degree in Biostatistics or closely related field with 9-14 years of relevant work experience.
• Professional working knowledge of theoretical and applied statistics.
• Strong statistical programming skills (SAS, R, or Python).
• 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.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 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.
• Experience working in the regulated industry (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 age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company's affirmative action program.

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