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Senior Statistical Programmer

India, Remote 求人ID 77002BR Category Statistical Programming
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About this Role

Responsibilities:

  • 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).

Requirements:

  • 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 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.
  • Demonstrate commitment to refine quality processes.• Good presentation skills.• Good business awareness/business development skills (including financial awareness).
応募

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