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Key Responsibilities
As a Principal Biostatistician at Parexel, you will work independently on clinical trial projects of varying complexity, often with significant regulatory implications. Your expertise in statistics will be recognized both internally and externally.
Operational Execution
- Provide statistical support for trial design, protocol, and CRF development on specific studies.
- Lead the production and quality control of randomization, analysis plans, statistical reports, and other supporting documents.
- Perform sample-size calculations, generate randomization lists, and write statistical methodology sections for inclusion in study protocols.
- Contribute to Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans.
- Support business development by actively contributing to study design considerations, providing and discussing sample size scenarios, and attending bid defense meetings.
General Activities
- Understand regulatory requirements related to therapeutic areas and their implications for statistical processing and analysis.
- Apply and provide training in advanced statistical methods.
- Contribute to the development and delivery of internal and external statistical training seminars and courses.
- Review position papers based on current good statistical practice.
- Interact with clients and regulatory authorities.
- Review publications and clinical study reports.
- Travel to and attend client meetings to discuss analysis concepts, present study results, and contribute to business development.
Requirements
- PhD or MS in Statistics or a related discipline with substantial experience.
- Competent in written and oral English, with proficiency in local languages.
- Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles.
- Prior experience with SAS programming required.
