An international pharmaceutical company is advertising a vacancy for a Biostatistician Head, based in Shanghai. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.
- Provide sound experimental design and data analysis expertise.
- Author the protocol statistical sections and generate statistical analysis plans and study randomization as needed.
- Review and sign off on relevant study documents and data management and programming deliverables.
- Prepare and review mockup tables, figures, and listings (TLFs); determine analysis and data presentation specifications for CRO programmers and statisticians.
- Partner with Medical Affairs and Commercial to provide statistical support for publications (Posters, Manuscripts etc.).
- Manage the CROs performing analysis; interpret study results and collaborate with medical and biostatistics staff to produce safety monitoring reports, interim and final reports, and publications.
- Represent the statistical function on project teams and in cross functional meetings.
- Supervise and lead the biometrics function to respond to all statistical needs.
- Work closely with medical, clinical sciences, clinical development operations, regulatory, research, project management, drug safety, and business development to optimize the design and conduct of studies, to generate data, to facilitate our interactions with regulatory agencies, business partners, presentations at scientific congresses and final manuscripts.
Skills and Requirements:
- D. in biostatistics, statistics, or a closely related field.
- Fluent in Chinese, native speaker preferred. Good command of English.
- 10+ years of experience in the support of clinical studies management and/or related work experience in a biotechnology or pharmaceutical company, or similar environment (e.g., CRO).
- 6+ years managing people.
- Must possess a comprehensive and detailed understanding of statistical experimental design and analysis, clinical trial requirements and statistical software packages such as SAS.
- Understanding of regulatory guidelines that affect statistical deliverables.
- Experience in immunology, hematology, and or oncology studies preferred.
- Experience with NDA and BLA submissions that a must including ISS, ISE development.
- Experience with regulatory interactions (FDA or EMA or NMPA).
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