临床试验SAS

【工作内容】
1) Ensure timely and quality development and validation of medium and above complexity datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/project
2) Interact and communicate with Statisticians, Data Mangers, Clinical Operations, Medical Monitors and Medical Writers to develop and validation of customized outputs
3) Comply with company, department and industry guidelines, Maintain supporting documentation for studies to ensure traceability and regulatory compliance
4) Critically reviews requirements and data, identifies gaps, proposes solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables.
5) Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents
6) Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results
7) Create standard macros and applications to improve the efficiency of the function
【任职要求】
1) BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field
2) In depth knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc.
3) Basic knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts
4) Demonstrated written and verbal communication skills
5) Ability to successfully work together with a team as well as independently