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パレクセルでの仕事

パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。

Senior Statistical Programmer

求人ID 77002BR ロケーション インド 仕事内容
• 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).

Qualifications

• 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).
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