Clinical Biostatistician II

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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.

The Clinical Biostatistician II, with general guidance from more experienced Statisticians, works individually and in collaboration with cross-functional teams to develop clinical evidence for molecular tests for screening, diagnosis, prognosis, monitoring, and therapy selection in oncology. This position plays an active role in planning projects and may be the technical lead responsible for the successful execution of the project, which involves exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Essential Duties

Include, but are not limited to, the following:

• Design clinical validity, clinical utility, health economics, and clinical experience studies.:
• Evaluate evidentiary requirements.
• Contribute to proposals, FDA pre-submissions, and study protocols (selecting endpoints, power and sample size calculations, and analysis plans).
• Review case report forms and data transfer requirements.
• Author statistical analysis plans.
• Apply rigorous statistical methodology and programming to:
  • Monitor 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.
• Demonstrated effective verbal and written communication and presentation skills.
• Effective communicator with ability to maintain open communication with team members, managers, and customers.
• Ability to regularly seek and integrate feedback from team members and managers in a professional manner.
• Ability to prioritize and drive to results with a high emphasis on quality.
• 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 and means to travel between local Exact Sciences locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Master's degree in Biostatistics or field as outlined in the essential duties; or Bachelor's degree in Biostatistics or field as outlined in the essential duties, plus 2 years of experience in lieu of a Master's degree.
• 4+ years of relevant work experience, as outlined in the essential duties.
• Demonstrated statistical experience in molecular diagnostic, drug, or medical device development; epidemiology; public health; or healthcare.
• Professional working knowledge of theoretical and applied statistics.
• Strong statistical programming skills (SAS, R, or Python).
• Strong verbal, written, and graphical communication/presentation skills.
• Proficiency with Microsoft Office programs, such as (Word, Excel, PowerPoint, Outlook, OneNote, etc.).
• Ability to work independently, prioritizing and producing high quality results.
• Ability to collaborate effectively as part of a cross-functional team.
• 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

• Experience in developing products for approval by regulatory authorities such as FDA.
• Experience with analytical validation.

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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