统计编程师(中国)Statistical Programmer I/II/Senior/Principal
Found in: Talent CN S2 - 2 weeks ago
When our values align, there's no limit to what we can achieve.
Job Description:
Job Purpose:
The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an
internal subject matter expert in specific areas providing technical support and expert advice, and works
independently to support various programing activities related to the analysis and reporting of clinical
study data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Lead role on
projects, and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional
areas as required. Further, the Senior Statistical Programmer will monitor quality, timelines, resource
allocation, and productivity in relation to budgets.
Key Accountabilities :
Project Management
Statistical Programming for Assigned Projects
Training
General
Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. Proactively participate in and/or lead process/quality improvement initiatives. Provide consultancy to internal and external sponsors with regard to statistical programming tasks. Represent Parexel at sponsor marketing and technical meetings. Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Develop knowledge of SAS and processes/procedures within other Parexel functional areasJob Qualifications:
Skills:
Excellent analytical skills. Proficiency in SAS. Extensive knowledge and understanding of the programming and reporting process. Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. Ability to learn new systems and function in an evolving technical environment. Strong project management skills. Strong organizational skills, ability to manage competing priorities, and flexibility to change. Attention to detail. Ability to successfully lead a global team. Work effectively in a quality-focused environment. Effective time management to meet daily metrics or team objectives. Show commitment to and perform consistently high-quality work. Business/operational skills that include customer focus, commitment to quality management, and problem solving. Demonstrate commitment to refine quality processes. Good presentation skills. Good business awareness/business development skills (including financial awareness).Knowledge and Experience :
Competent in written and oral English. Excellent communication skills. Education:
Educated to degree level in a relevant discipline and/or equivalent work experience.-
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