[Remote] Clinical Biostatistician II

Note: The job is a remote job and is open to candidates in USA. Exact Sciences is dedicated to changing how the world prevents and detects cancer. The Clinical Biostatistician II will collaborate with cross-functional teams to develop clinical evidence for molecular tests and will play a key role in planning and executing projects.

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
• 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

Skills

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

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
• Bonus eligible

Company Overview

Company H1B Sponsorship