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- Statistical Programmer I (Bucharest, Romania)
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Statistical Programmer I (Bucharest, Romania)
Parexel International Corporation
Bucharest, București, Romania
Job Purpose:
The Statistical Programmer I works with supervision to support various programming activities related to the analysis and reporting of clinical study data.
Key Accountabilities:-
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 low-medium complexity derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.
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.
General
• Maintain all supporting documentation for studies in accordance with SOP's / Guidelines to ensure traceability and regulatory compliance.
• Ensure compliance with SOP's / Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.QualificationsSkills:
• Excellent analytical skills with sound SAS programming knowledge & skills.
• Knowledge and understanding of the programming and reporting process.
• Knowledge of SOP's / 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.
• 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.
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.
Job posted: 2020-08-14