Principal Clinical Biostatistician

$129,000 - $208,000/Yr

Exact Sciences - San Diego, CA

Full-time - Senior

San Diego, CA

Professional, Scientific, and Technical Services

About the position

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. 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.

Responsibilities

• 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, reviewing case report forms and data transfer requirements, and 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, and 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.
• Evaluates investigator sponsored study designs and analysis plans, evidence developed for external molecular tests, and applicability of novel statistical techniques.

Requirements

• 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.

Nice-to-haves

• 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).

Benefits

• Paid time off (including days for vacation, holidays, volunteering, and personal time)
• Paid leave for parents and caregivers
• Retirement savings plan
• Wellness support
• Health benefits including medical, prescription drug, dental, and vision coverage