Biostatistical Expert
3 weeks ago
Key Responsibilities
- Provide statistical support for trial design, protocol, and CRF development.
- Lead production and quality control of randomization, analysis plans, statistical reports, and other process supporting documents.
- Perform sample-size calculations, generate randomization lists, and write statistical methodology sections for study protocols.
- Provide statistical input into Data Monitoring Committee (DMC) activities, including DMC charters and analysis plans.
General Activities
- Understand regulatory requirements related to therapeutic areas and statistical processing and analysis implications.
- Understand and apply advanced statistical methods.
- Contribute to internal and external statistical training seminars and courses.
- Review position papers based on current good statistical practice.
- Interact with clients and regulatory authorities.
Requirements
- PhD or MS in Statistics or related discipline with substantial experience.
- Competent in written and oral English.
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