Statistical Programmer I (Bucharest, Romania) in Bucuresti

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.2020-08-14 01:01:22