Clinical Database Programmer I

Key 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.QualificationsSkills

• 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.