Clinical Data Programmer III - SAS

The Clinical Data Programmer SAS III (CDP III SAS) is responsible for developing SAS-based data analyses, reports, visualisations, and dashboards using study-related clinical and operational data. The role supports clinical data review, data quality and integrity, risk identification, and study performance oversight, enabling timely and informed decision-making throughout the study lifecycle. The CDP III SAS works closely with a broad range of study stakeholders, including Data Management (DM), Medical Monitoring (MM), Clinical Monitoring (CM), Project Management (PM), and other clinical and operational functions.

Minimum Qualifications & Experience:

A graduate qualification in computer science, data science, mathematics, life sciences or a related field. A minimum of three years’ relevant experience in statistical programming, business intelligence, data analysis or data science within a pharmaceutical company, CRO or EDC software provider. Practical experience using SAS and/or business intelligence tools (e.g. Power BI, TIBCO Spotfire), to interrogate clinical, laboratory or operational datasets is required. Exposure to additional analytics, RBQM, centralised monitoring or workflow automation platforms is desirable.

Desirable Attributes and Skills:

• Good knowledge of clinical study data structures, EDC database schemas and clinical data review processes.
• Strong knowledge of data processing activities, including extracting, integrating, transforming, analysing and presenting data.
• Practical programming capability in SAS; experience with SQL, Python, R or similar languages is desirable.
• Working knowledge of one or more data visualisation and analytics platforms, such as Spotfire, Power BI, Tableau or Qlik.
• Experience with RBQM and centralized monitoring platforms, such as Medidata Clinical Data Studio (CDS) and CluePoints.
• Experience with clinical data review, reporting, and workflow automation tools, such as JReview and Power Automate.
• Experience gathering business and user requirements from multiple stakeholders and translating them into clear, fit-for-purpose analytical solutions.
• Awareness of regulatory and compliance requirements, with the ability to apply SOPs, validation practices and quality control principles to daily activities.

Responsibilities:

The Clinical Data Programmer SAS III (CDP III SAS) partners with clinical study teams and other stakeholders to define, develop, validate, deploy and maintain fit-for-purpose programming and analytics solutions, including dashboards, graphs, tables, listings and reports.

Project/Clinical Studies

• Partner with CDMs, CDRs, PMs and other study stakeholders to define clinical, laboratory, external and operational data requirements and recommend fit-for-purpose dashboards, visualisations, listings and reports.
• Manage assigned programming deliverables from requirements gathering and specification through development, testing, deployment, maintenance and change control in accordance with applicable procedures.
• Extract, integrate, transform and analyse clinical study data from EDC, laboratory, operational and other sources using SAS and relevant technologies.
• Develop validated, reusable programs and analytical outputs that support data inspection, reconciliation, clinical and medical review, operational oversight and timely study decision-making.
• Develop and maintain analytics supporting risk-based quality management and centralised monitoring, including key risk indicators, quality tolerance limits, site performance oversight and identification of meaningful data trends and quality signals.

Clinical Data Visualisation Team

• Participate actively in Clinical Data Visualisation team, project and Biometrics department meetings.
• Share technical knowledge, contribute to team learning and support the development of less-experienced colleagues.
• Collaborate effectively across functions to support consistent, high-quality study delivery.

Software Tools

• Maintain proficiency in SAS and relevant business intelligence, clinical data visualisation, data review and analytics technologies.
• Evaluate and apply fit-for-purpose technologies such as Power BI, Spotfire, Medidata Clinical Data Studio, CluePoints, SQL, Python, R and workflow automation tools, according to project and business needs.
• Develop reusable templates, macros, standard programs and automated solutions that improve quality, consistency, scalability and delivery efficiency.

Clinical Data Visualisation Processes and SOPs

• Ensure deliverables comply with Novotech corporate SOPs, applicable regulatory guidelines, validation requirements, data integrity principles and quality control standards.
• Prepare and maintain clear user requirements, specifications, test evidence and other documentation necessary to support validated and inspection-ready solutions.
• Apply approved procedures, best-practice instructions and templates for clinical data programming, analytics and visualisation activities.
• Contribute to SOPs, templates, technical standards, guidance documents, process improvement, quality control and governance initiatives.