Statistical Programmer II Guangzhou

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: Project Management - Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.

Statistical Programming for Assigned Projects - Deliver best value and high quality service. - Check own work in an ongoing way to ensure first-time quality. - Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings. - Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation. Training - Maintain and expand local and international regulatory knowledge within the clinical industry. - Develop knowledge of SAS and processes/procedures within other Parexel functional areas. - Provide relevant training and mentorship to staff and project teams as appropriate.

General - Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulator 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 process/quality improvement initiatives. - Understand regulatory

Requirements

concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills: - Excellent analytical skills. - Proficiency in SAS. - 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. - Ability to manage competing priorities and flexibility to change. - Attention to detail. - Ability to successfully work as part of a global team. - Work effectively in a quality-focused environment. - Effective time management in order 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.

Knowledge and Experience: - Competent in written and oral English. - Good communication skills. Education: - Educated to degree level in a relevant discipline and/or equivalent work experience. Apply directly on RemoteJobs.org: https://remotejobs.org/remote-jobs/statistical-programmer-ii-guangzhou-parexel