Clinical Biostatistician II

Clinical Biostatistician II at Exact Sciences

• Join our team to help change how the world prevents, detects, and treats cancer. We provide patients and clinicians with the clarity needed to make confident decisions.

The Senior Clinical Biostatistician works under general guidance from more experienced Statisticians, collaborating with cross‑functional teams to develop clinical evidence for molecular tests in oncology. The role may act as the technical lead, exercising judgment on methods and techniques within defined practices and policies.

• Design clinical validity, 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; conduct simulation studies.
• Communicate statistical results in tables, figures, and listings; produce analysis reports, clinical study reports, abstracts, manuscripts, regulatory submissions, presentations, and marketing collateral.
• Evaluate investigator‑sponsored study designs and analysis plans; assess evidence for external molecular tests and applicability of novel techniques.
• Demonstrate effective verbal and written communication and presentation skills; maintain open communication with team members, managers, and customers.
• Prioritise 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 company Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Act with an inclusion mindset and model inclusive behaviors.
• Work on a mobile device, tablet, or computer for ~90% of the workday.
• Travel up to 5% of working time, including overnight or weekend travel.

• Master’s degree in Biostatistics or related field, or Bachelor’s degree with 2 years of experience in lieu of an advanced degree.
• 4+ years of relevant work experience.
• Statistical experience in molecular diagnostics, 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 (Word, Excel, PowerPoint, Outlook, One Note).
• Ability to work independently and collaborate as part of a cross‑functional team.
• Demonstrated ability to perform essential duties with or without accommodation.
• Authorization to work in the United States without sponsorship.

• 8+ years of relevant experience.
• Experience developing products for approval by regulatory authorities such as the FDA.

Salary range: $82,000.00 - $ (national range; may vary by location). The role is bonus eligible.

Benefits include paid time off (vacation, holidays, volunteering, personal time), parental leave, retirement savings plan, wellness support, and comprehensive health coverage (medical, prescription drugs, dental, vision).

Exact Sciences is 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 law. If you require an accommodation, please contact us.