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Senior Statistical Programmer (UK) FSO

Parexel International Corporation

Sheffield, England, United Kingdom

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). Produce/QC dataset specifications and other process supporting documents and submission documentation.

• Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements.QualificationsExcellent 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).

Job posted: 2022-04-01

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