Clinical Research Coordinator II at University of South Florida responsible for coordinating clinical research activities and ensuring participant data quality. Serving as main contact for sponsors and patients for specific research protocols.
About the role
- Clinical Biostatistician developing clinical evidence for molecular tests related to cancer screening and treatment at Exact Sciences. Collaborating with cross-functional teams while applying rigorous statistical methodologies.
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.
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.
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
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