Clinical Programmer

November 3

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AIXIAL GROUP

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Biometrics and Clinical Research • Contract Research Organisation • biostatistics • data-management • E-CRF

1001 - 5000

Description

• The Clinical Programmer is responsible for providing Clinical Programming input per Data Management activities. • Responsible for ensuring all clinical programming aspects per client work orders are delivered to high regulatory standards and Aixial Group SOPs. • Responsible for programming and execution of listings, using different languages as per protocol / requirements. • Responsible for designing reports and patient profiles. • Understands and strictly follows Aixial and Client’s SOPs, guidelines, and appropriate local and international legislation. • Clinical Programmer works under the supervision of more senior staff (manager, Team Leader, Clinical Programming, or senior Clinical Programmer). • Work closely with the Lead Data Manager on assigned projects. • Responsible for drafting Data Integration Specifications for external data vendors integration and to manage external data loading and integrations. • Responsible for the SAS datasets maintenance and data transfers per data transfers agreement. • Participate study documentation archiving. • Participate in regulatory audits and inspections as required. • May undertake other tasks as assigned by Line Manager.

Requirements

• Bachelor’s degree qualification in a Scientific discipline is preferred. • 4 or more years as a Clinical Programmer or equivalent combination of education, training and experience. • Knowledge and understanding of ICH GCP and other relevant ICH, EU, or FDA guidelines to maintain regulatory compliance. • Understanding of Clinical trial process and Data management activities. • Experience with programming languages, such as SAS, SQL, Python, R, JavaScript, C#. • CDASH standards experience desirable. • Proficient in computer technology used in an office environment (Word, Excel, PowerPoint, MS Project, etc.) • Fluent English: Read, Written, Spoken.