统计经理-上海

该职位来源于猎聘 职责描述： Provides statistical support to development and clinical research projects; interacts with research personnel to ascertain their needs and develop appropriate design and statistical solutions. Writes data analysis plans and statistical reports for use by internal and external stakeholders. Critiques and improves study designs developed by other groups, and plays an active role in organizational surveillance to ensure statistical quality.

Has primary ownership of at least several major projects and actively mentors less experienced colleagues as needed. 1、Interact with clinical scientist and clinical investigators to design clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims. 2、Write/review data analysis plans as needed to capture design elements and statistical methodology. 3、Perform data analysis and prepare/review oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory authorities, or individual investigators. 4、Maintain expertise in state-of-the-art data manipulation and statistical analyses, including knowledge of novel statistical methodology and available software. 5、Perform Quality Control (QC) for statistical analyses by vendor biostatisticians to ensure analysis quality. 6、Conduct randomization and blinding of randomized, double-blinded trials. 7、Troubleshoot and improve current statistical designs, including those developed elsewhere 8、Evaluate databases and statistical analysis programs and interact with vendor programming groups and monitor their work to ensure quality and timeline. 9、Participate in discussions with corresponding scientific personnel including but not limited to regulatory agencies and investigators concerning proposed or ongoing studies 10、Involved in research activities for innovative statistical methods and applications in clinical trial development 任职要求： 1、2+ (with Ph.D) and 5+ (with master’s degree) years of clinical development experience in pharmaceutical and/or biotech industry (including CROs) with a proven successful track record in pharmaceutical development. 2、Sound knowledge of the ICH guidelines. Understanding of the regulatory requirements from NMPA. 3、Good knowledge of statistical methodology and working experience in oncology projects. 4、Experience with sample size software. 5、Good knowledge in clinical study related SAS and/or R programming. 6、Able to explain statistics in a non-technical manner to non-statisticians. Able to collaborate effectively with internal and external teams.