Statistical Programmer II (FSO) South Africa

Parexel International Corporation

Bloemfontein, Orange Free State, South Africa

• 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.

• 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).Qualifications• 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.

2022-06-22 00:05:23

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