What are the responsibilities and job description for the Principal Clinical Biostatistician position at Exact Sciences Careers?
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At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.
Position Overview
The Principal Biostatistician collaborates with cross-functional teams to develop clinical evidence for molecular tests for screening, diagnosis, prognosis, monitoring, and therapy selection in oncology.
Essential Duties
Independently and effectively represents the biostatistical function for a product, providing strategic input and contributing significantly to objectives in creative ways.
Designs and advises the design of clinical validity, clinical utility, health economics, and clinical experience studies by :
Evaluating evidentiary requirements
Contributing to proposals, FDA pre-submissions, and study protocols (selecting endpoints, power and sample size calculations, and analysis plans)
Reviewing case report forms and data transfer requirements
Authoring and reviewing statistical analysis plans
Applies complex statistical methodology and programming to :
Monitor clinical data quality
Develop evidence for clinical predictive models in clinical studies and trials
Conduct simulation studies
Communicates 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.
Minimum Qualifications
Master’s degree in Biostatistics or closely related field with 9-14 years of relevant work experience.
Professional working knowledge of theoretical and applied statistics.
Strong statistical programming skills (SAS, R, or Python).
Strong verbal, written, and graphical communication / presentation skills.
Ability to regularly seek and integrate feedback from team members and managers in a professional manner.
Ability to work independently, prioritizing and producing high quality results.
Ability to collaborate effectively as part of a cross-functional team.
Authorization to work in the United States without sponsorship.
Preferred Qualifications
Experience in molecular diagnostic, drug, or medical device development; epidemiology; public health; or healthcare.
Experience in developing products for approval by regulatory authorities such as FDA.
Experience working in the regulated industry (FDA or EU).#LI-AN1Salary Range : $129,000.00 - $208,000.00The annual base salary shown is a national range for this position on a full-time basis and may differ by hiring location. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually.Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our [benefits](https : / / careers.exactsciences.com / benefits).Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us [here](mailto : neo@exactsciences.com?subject=Exact Sciences Recruiting).Not ready to apply? Join our [talent community](https : / / careers.exactsciences.com / talent-community) and stay up to date on what’s new at Exact Sciences.We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company’s affirmative action program.To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our [compliance hub](https : / / exactsciences.box.com / s / gj6pxvld7g6rnhvum3cttfdevppp34s2). The documents summarize important details of the law and provide key points that you have a right to know.
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Madison, WI
Full Time