This is a Statistical Programming role, which needs you to lead projects and manage vendors.
Your new role
1. Serve as the responsible programmer for the projects. Responsible for the production and validation of clinical trial report deliverables, including analysis datasets and specifications, well-documented SAS® code, summary tables, figures, listings internally or from our vendors.
2. Help to develop and maintain statistical programming SOPs. Help to develop and maintain Data Standards.
3. Responsible for all statistical programming tasks including submission-readiness datasets and TFLs to support CSR, ad hoc analysis, publications, DSUR, and etc.
4. Prepare/Review electronic submission deliverables consistent with regulatory guidelines.
5. Ensure compliance with FDA and NMPA regulations related to statistical programming including vendors/CROs.
6. Oversee and ensure quality of all statistical programming activities performed by CROs.
7. Actively communicate with Data Management, Biostatistics, Clinical Operations, Medical/Clinical, safety colleagues, RA and vendors in support of project deliverables and regulatory needs.
What you'll need to succeed
Minimum of bachelor’s degree in biological, statistical, computer science, or related field. Master’s degree preferred.
A minimum of 5 years of relevant SAS programming experience in pharmaceutical or biotechnology industry is required. Oncology experience is highly desired.
Comprehensive knowledge of ICH/FDA/NMPA guidelines.
Expert knowledge in SAS is required.
Knowledge and experience of CDISC standards are required.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1223649
Talk to a consultant
Talk to Lunah Wang, the specialist consultant managing this position, located in Shanghai
Unit 1205-1212, HKRI Centre One, HKRI Taikoo Hui, 288 Shimen Road (No.1)