Senior Biostatistical Expert
2 weeks ago
About the Role
The Senior Biostatistical Expert will provide high-level statistical support across all complexity levels of clinical trials, with a strong focus on regulatory impact.
Key Responsibilities
- Develop and implement trial designs, protocols, and CRF configurations.
- 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 study protocols.
- Collaborate with Data Monitoring Committee (DMC) activities, including charter and analysis plan development.
- Provide statistical input and support for DMC reviews.
- Stay up-to-date with regulatory requirements and implications for statistical processing and analysis.
- Develop and deliver 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 for client meetings, presenting and discussing analysis concepts and study results.
Requirements
- PhD or MS in Statistics or a related field with at least 6 years of experience.
- Competency in written and oral English, with local language proficiency.
- Knowledge of pharmacokinetic data is an advantage.
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