Collaborates with interdisciplinary, cross-functional teams to develop and establish evidence for molecular tests for screening, diagnosis, prognosis, monitoring, and therapy selection in oncology
Assist the biostatistical function on project-level work
Provide input into the design of analytical validity, clinical validity, clinical utility, health economics, and clinical experience studies
Evaluate evidentiary requirements
Contribute to proposals, FDA pre-submissions, and study protocols
Review case report forms and data transfer requirements
Draft statistical analysis plans
Monitor laboratory and clinical data quality
Develop evidence for clinical predictive models in clinical studies and trials
Conduct simulation studies
Communicate statistical results in various formats
Evaluate investigator-sponsored study designs and analysis plans

Master’s degree in Biostatistics or related field
Working knowledge of theoretical and applied statistics
Strong statistical programming skills (SAS, R, or Python)
Basic computer skills to include internet navigation and email usage
Working knowledge of Microsoft Office programs, such as Word, Excel, PowerPoint, Outlook, Access, OneNote, and Publisher
Demonstrated ability to perform the essential duties of the position with or without accommodation
Authorization to work in the United States without sponsorship
2 years of relevant work experience (preferred)
Experience in molecular diagnostic, drug, or medical device development; epidemiology; public health; or healthcare (preferred)
Experience in developing products for approval by regulatory authorities such as FDA (preferred)

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

Clinical Biostatistician I

Key skills