生物统计总监/高级总监

Responsibilities：

Designs, plans, and executes statistical components of clinical trials. Uses sound statistical methodology to conduct

studies, prepares the statistical components of protocols, and is responsible for statistical analysis plan and the statistical components of reports.

· Serves as the lead biostatistician on project teams for clinical studies.

· Contributes to molecule’s clinical development plan, clinical study protocols and clinical study reports.

· Participates in the development and review of CRFs, edit specifications, and critical variable lists.

· Reviews randomization specifications and dummy randomizations.

· Develops statistical analysis plans and reporting specifications for clinical studies.

· Performs lead review of TFLs and derived datasets for clinical studies.

· Oversees statistical analyses performed by CROs and interprets results for clinical studies.

· Participates in meetings with health authorities.

For people management role:

· Leads the biostatistics group and data science group as applicable.

· Recruits, retains, mentors, and trains talents.

· Ensures compliance to the applicable guidance and SOPs of the group.

Qualifications：

· MSc or PhD in statistics, biostatistics, mathematics or similar areas of academic discipline.

· At least 5 years of experience working in industry.

· Experience in using statistical software.

· Good knowledge of theoretical and applied statistics.

· Very good knowledge and experience applying statistical methods to drug development.

· Good understanding of regulatory guidelines in a pharmaceutical research setting.

· Understands and applies Business requirements and processes.

· Excellent team player.