Clinical Trial Manager at ICON managing trial operations, ensuring high - quality outcomes and compliance with trial protocols for clinical development in Beijing and Shanghai.
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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