Clinical Biostatistician II Job at Exact Sciences (Madison)

Job Description

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.

Job Responsibility

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

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 have

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

What we offer

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 eligibility

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Clinical Biostatistician II

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