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Exact Sciences · 4 days ago

Clinical Biostatistician II

United States

Full-time

Remote

Mid, Senior Level

$88K/yr - $133K/yr

4+ years exp

Exact Sciences is helping change how the world prevents, detects and guides treatment for cancer. The Clinical Biostatistician II will work collaboratively with cross-functional teams to develop clinical evidence for molecular tests in oncology, playing an active role in project planning and execution.

BiotechnologyHealth DiagnosticsManufacturingMedical

No H1B

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

Qualification

BiostatisticsStatistical programmingClinical study designMolecular diagnosticsFDA submissionsQuality resultsMicrosoft OfficeCommunication skillsTeam collaboration

Required

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