Senior Statistical Programmer (UK) FSO

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).

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Job Overview

ID:

628173

Date Posted:

Posted 1 week ago

Expiration Date:

22/07/2022

Location:

Chorley

Salary:

Competitive

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