上海招聘

1、Provides comprehensive programming leadership and support to clinical trials, including timely programming deliverables with high quality and coordination with other functions for the planning of programming support.
2、Oversees external vendors for their programming activities including timely deliverables with high quality and ensures their programming practice to be compliant with relevant company SOPs and regulatory requirements.
3、Develops and maintains CDISC-compliant and submission-ready SAS programs, SDTM, ADaM, datasets specifications, and summary TLFs (tables, listings, and figures).
4、Ensures programming infrastructure in place to support integrated summaries (ISE/ISS/SCE/SCS), CSR, conference, abstracts, publication manuscripts, ad-hoc analyses, and other requested regulatory deliverables.
5、Oversees the development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, and supporting development plans.
6、Ensures the deployment of programming strategies, standards, and specifications to comply with regulatory specific requirements, company and departmental SOPs, and work practices.
7、Actively contributes to and participates in company’s and departmental activities including staff recruitment, onboarding process, knowledge sharing, and supporting development initiatives.

任职要求：
1. Minimum of 9 years of SP experience in clinical trials and regulatory submissions.
2. Highly competent in SAS programming and Macro development.
3. Thorough understanding of ICH and NMPA’s guidelines and relevant regulatory requirements.
4. Extensive knowledge of CDISC SDTM and ADaM data models and their applicability to clinical trial database design, data capture and reporting.
5. Knowledge in integrating SAS with other leading programming technologies such as Microsoft Office, R, etc.
6. Mastery of SAS programming concepts and skills relevant to biopharmaceutical industry.
7. Ability to effectively manage multiple projects simultaneously with time-sensitive deliverables.
8. Experience in the analysis of complex clinical trial data.
9. Excellent communication and inter-personal skills.

Overland Pharma is a newly founded biopharma company. Our vision is to become a game changer in bringing innovative and important medicines to underserved patients in Asia. We are establishing a pipeline of innovative programs through business development and partnering efforts in a few carefully selected therapeutic areas.