Principal Statistician

RESPONSIBILITIES: · Serve as statistical representative in the cross-functional teams for the statistical strategic planning of compound development, lead the statistical design of clinical trials conducted both in China and Globally. · Prepare or review statistical related sections in clinical trial protocols, clinical trial reports, regulatory submissions, publications and ensure appropriate statistical interpretation in these documentations. · Develop statistical analysis plans (SAP) or oversees SAP development. · Lead programmer team to do analysis planning and ensure all analysis specified in protocols and analysis plans are conducted appropriately and deliver timely with high-quality. · Perform statistical check to validate trials key results produced by CRO or programmer team. · Serve as statistical representative in clinical trials team and oversees trial conducts from statistical perspective, such as events monitor or prediction, data quality check. · Under the guidance of superior statisticians to do regulatory communication on trials design, regulatory queries address in IND or NDA submissions in both China and global submission. · Oversee process and quality of statistical work contracted out to a CRO or research collaborator. · Involve in research activities for innovative statistical methods and applications in clinical trial development. · Mentor junior colleagues in techniques, processes. Qualifications: · PhD (with 4+ years of experience in pharma) or MS (with7+ years of experience in pharma) in statistics, Biostatistics, Applied Mathematics, or other related majors. · Have experience in oncology phase III study design or NDA submission experience as sponsor statistician. · Thorough knowledge of statistical methodology, pharmaceutical research and development strategies and execution, GCP and regulatory guidelines. · High degree of technical competence and excellent written and verbal communication skills in both Mandarin and English. · Strong time management and prioritization skills · Familiarity with statistical tools such as SAS (or R), PASS, East. · Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.