Develop, test and document programming code to transform, analyse and report clinical and real-world datasets
Support SDTM, ADaM and TFL activities, including development, validation and review of study and standard programs for clinical trial data conversion, analysis and reporting
Produce validated datasets, tables, listings and figures in line with agreed standards, protocols, timelines and change control processes
Review and quality check programming code, outputs and documentation to ensure accuracy, compliance and reproducibility
Collaborate with statisticians, data scientists and study teams to implement analysis plans, answer technical questions and contribute to programming best practices
Apply knowledge of GxP, ICH requirements, internal processes and external regulations while helping introduce innovative tools and approaches within an agile delivery organisation
Requirements
Degree in Mathematics, Statistics, Computer Science, or a related subject, or equivalent practical experience
Programming experience in a pharmaceutical, biotechnology, CRO industry, having worked in reporting clinical trials using CDISC standards
Practical programming skills such as R, Python, etc.
Experience producing validated outputs from clinical or observational datasets
Strong attention to detail and experience performing code reviews or quality control
Clear written and verbal communication skills for cross-functional teamwork