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Senior Statistical Programmer (SAS Programmer) South AfricaJob ID 80569BR Bloemfontein, Orange Free State, South Africa
• Ability to fill Statistical Programming Lead role on projects
o Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
o Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
o Monitor project resourcing, project budgets, and identify changes in scope.
• Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
• Review statistical analysis plans and mock-shells.
• Review database set-up specifications.
• Interact with sponsors and internal stakeholders with regard to statistical programming issues.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work.
• 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/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.
• 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.
• 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.
• 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).
Qualifications• Excellent analytical skills.
• Proficiency in SAS with sound programming experience.
• 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.
• Strong organizational skills, ability to manage competing priorities, and flexibility to change.
• Attention to detail.
• Work effectively in a quality-focused environment.
• Effective time management in order to meet daily metrics or team objectives.
• Business/operational skills that include customer focus, commitment to quality management, and problem solving.
• Competent in written and oral English.
• Excellent communication skills.
• Educated to degree level in a relevant discipline and/or equivalent work experience.
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