Clinical Biostatistician II

Exact Sciences • Bethel Manor, VA

6d • $84,000 - $153,600 • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• 8+ years of relevant work experience, as outlined in the essential duties.
• Experience in developing products for approval by regulatory authorities such as FDA.

Responsibilities

• 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.
• 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.
• Act with an inclusion mindset and model these behaviors for the organization.

Benefits

• paid time off (including days for vacation, holidays, volunteering, and personal time)
• paid leave for parents and caregivers
• a retirement savings plan
• wellness support
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree