Senior Statistical Programmer
Statistical Programmer at global clinical research organization Parexel in Taipei, producing and QC-ing clinical trial derived datasets (SDTM/ADaM), tables, figures, and listings in SAS for regulatory submissions. The role also covers project start-up coordination, documentation, audit support, and mentoring, within ICH-GCP/CDISC compliance standards.
- Compensation
- Not disclosed
- Location
- Taiwan-Taipei
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- Not specified
- Category
- Not specified
- Posted
Skills
Must have
- Proficiency in SAS
- Excellent analytical skills
- Knowledge and understanding of the programming and reporting process
- Knowledge of SOPs/Guidelines, ICH-GCP, and applicable regulations such as 21 CFR Part 11
- Understanding of regulatory requirements for industry technical standards (e.g. CDISC, 21 CFR Part 11, electronic submissions)
- Educated to degree level in a relevant discipline and/or equivalent work experience
- Competent in written and oral English
- Good communication skills
- 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 with consistently high-quality work
- Effective time management to meet daily metrics or team objectives
- Business/operational skills including customer focus, commitment to quality management, and problem solving
Full description
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.