工作职责：

1.1 Independently complete relevant statistical programming tasks for the assigned clinical trial projects, ensuring high-quality work and timely delivery.
1.2 Collaborate closely with the project team, participate in related research group meetings, such as BDR meetings.
1.3 Provide necessary technical guidance to vendors during the project, proactively follow up on project progress to ensure the achievement of key milestones in statistical programming.
1.4 Responsible for documentation maintenance and TMF archiving of clinical data statistical programming.
1.5 Adhere to the company's standard operating procedures and propose suggestions for standard operating procedures based on project experience.
1.6 Support internal and external audit work, communicate effectively with regulatory authorities regarding project-level processes and activities.
1.7 Provide training related to statistical programming, responsible for the training of relevant personnel in the project team, etc.
1.8 Complete other tasks assigned by the immediate supervisor.

任职资格：

2.1 Bachelor/Master or above degree in a scientific discipline or health related field.
2.2 At least 4 Years of experience of statistical programming experiences in the pharmaceutical industry.
2.3 Familiar statistical programming relevant regulatory guidelines.
2.4 Experiences of supporting IND and NDA submission is preferred.
2.5 Good knowledge of the CDISC standards.
2.6 Specialty and experience in oncology study is preferred.
2.7 Proficient in English.