[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.ResponsibilitiesDesign clinical validity, clinical utility, health economics, and clinical experience studiesEvaluate evidentiary requirementsContribute 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 requirementsAuthor statistical analysis plansApply rigorous statistical methodology and programming to: Monitor clinical data quality Develop evidence for clinical predictive models in clinical studies and trials Conduct simulation studiesCommunicate statistical results in tables, figures, and listings; statistical analysis reports; clinical study reports; abstracts; manuscripts; regulatory submissions; presentations; and marketing collateralEvaluate investigator sponsored study designs and analysis plans, evidence developed for external molecular tests, and applicability of novel statistical techniquesDemonstrated effective verbal and written communication and presentation skillsEffective communicator with ability to maintain open communication with team members, managers, and customersAbility to regularly seek and integrate feedback from team members and managers in a professional mannerAbility to prioritize and drive to results with a high emphasis on qualityUphold company mission and values through accountability, innovation, integrity, quality, and teamworkSupport and comply with the company’s Quality Management System policies and proceduresMaintain regular and reliable attendanceAbility to act with an inclusion mindset and model these behaviors for the organizationAbility 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 dayAbility and means to travel between local Exact Sciences locationsAbility to travel 5% of working time away from work location, may include overnight/weekend travelSkillsMaster'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 degree4+ years of relevant work experience, as outlined in the essential dutiesDemonstrated statistical experience in molecular diagnostic, drug, or medical device development; epidemiology; public health; or healthcareProfessional working knowledge of theoretical and applied statisticsStrong statistical programming skills (SAS, R, or Python)Strong verbal, written, and graphical communication/presentation skillsProficiency with Microsoft Office programs, such as (Word, Excel, PowerPoint, Outlook, OneNote, etc.)Ability to work independently, prioritizing and producing high quality resultsAbility to collaborate effectively as part of a cross-functional teamDemonstrated ability to perform the essential duties of the position with or without accommodationAuthorization to work in the United States without sponsorship8+ years of relevant work experience, as outlined in the essential dutiesExperience in developing products for approval by regulatory authorities such as FDABenefitsPaid time off (including days for vacation, holidays, volunteering, and personal time)Paid leave for parents and caregiversA retirement savings planWellness supportHealth benefits including medical, prescription drug, dental, and vision coverageBonus eligibleCompany OverviewExact Sciences offers a portfolio of cancer screening and diagnostic tests that span from early detection to treatment monitoring. It is a sub-organization of Abbott. It was founded in 1995, and is headquartered in Madison, Wisconsin, USA, with a workforce of 5001-10000 employees. Its website is https://www.exactsciences.com.Company H1B SponsorshipExact Sciences has a track record of offering H1B sponsorships, with 3 in 2026, 33 in 2025, 10 in 2024, 19 in 2023, 33 in 2022, 3 in 2021. Please note that this does not guarantee sponsorship for this specific role.