Principal Biostatistician

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Principal Biostatistician

責任

1. Provide scientifically rigorous statistical input to protocols, statistical analysis plans, interpretation of statistical results, and scientific publications.

2. Ensure delivery of high-quality, effective, and timely study or indication-level statistical deliverables for assigned projects.

3. Foster effective collaborations with internal and external stakeholders.

4. Ensure compliance with relevant regulatory requirements, OBI SOP and best practice across all study or indication-level statistical activities.

5. Serve as a comprehensive resource for clinical development, data management and statistical matters

6. Contribute to non-project activities within Biostats department.

資格

Experience, education, or skills required of the incumbent in this position:

• MS degree in statistics/biostats with 5+ years or Ph.D. with 3+ years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.

• Experience in oncology drug development.

• Demonstrated ability to work independently in project management and decision making.

• Able to effectively communicate his/her ideas and work with cross functional teams in a constructive manner.

• Ability to use SAS to perform statistical analyses and validate important data derivations when necessary.