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.

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

Education

• First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience

Language Skills

• Competent in written English.
• Good communication skills.

Minimum Work Experience

• Relevant Clinical Trial industry experience