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Statistical Programmer ( all levels )
Job ID 62613BR Shenyang Wobu, Liaoning, ChinaKey Accountabilities
• Deliver best value and high quality service.
• Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
• Assist in the coordination of project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g. setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
• Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents.
• Use efficient programming techniques to produce derived datasets, tables, figures and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures and data listings.
• Check own work in an ongoing way to ensure first-time quality.
• Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
•Proactively participate in quality improvement initiatives.
• Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.
• Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.
• Provide relevant training and mentorship to staff and project teams as appropriate.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work.
• Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.
• Develop mapping specification for data exports in accordance with applicable standards.
• Deliver best value and high quality service.
• Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
• Assist in the coordination of project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g. setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
• Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents.
• Use efficient programming techniques to produce derived datasets, tables, figures and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures and data listings.
• Check own work in an ongoing way to ensure first-time quality.
• Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
•Proactively participate in quality improvement initiatives.
• Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.
• Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.
• Provide relevant training and mentorship to staff and project teams as appropriate.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work.
• Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.
• Develop mapping specification for data exports in accordance with applicable standards.
Qualifications
| Skills • Proficiency in SAS. • Knowledge of the programming and reporting process. • Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application. • Demonstrate ability to learn new systems and function in an evolving technical environment • Attention to detail. • Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently. • Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change. • Business/Operational skills that include customer focus, commitment to quality management and problem solving. • 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. |
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