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Statistical Programmer II

Taipei, Taipei City, Taiwan 求人ID R0000019109 Category Statistical Programming
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About this Role

Job Description

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 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 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.
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