Senior Biostatistician Consultant
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Job Description
Senior Manager, Biostatistician Consultant at Parexel delivering advanced statistical support for clinical trials and regulatory needs. Engaging with clients, leading statistical training, and ensuring quality data analysis.
Responsibilities:
- Provide broad statistical support, including trial design, protocol and CRF development on specific studies
- Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
- Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols
- Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis
- Interact with clients and regulatory authorities
- Review publications and clinical study reports
Requirements:
- PhD in Statistics or related discipline, MS in Statistics or related discipline
- Prior experience with SAS programming required
- Thorough understanding of statistical issues in clinical trials
- Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)
Benefits:
- Travel to, attend, and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results)
- Contribute to the development and delivery of internal and external statistical training seminars and courses
- Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review
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