Statistical Programmer II (Sheffield OR Uxbridge, UK)

Company
PAREXEL
Location
Sheffield, England,United Kingdom
Salary
Competitive
Posted
07 Dec 2018
Closes
09 Feb 2019
Ref
49616BR
Key Accountabilities:
Accountability Supporting Activities
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
• 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).QualificationsSkills:
• 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.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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