Professional Summary
Senior Statistical Programmer with over 10 years of experience designing and validating complex statistical analysis plans in clinical research. Specialises in SAS programming, data visualisation, and automation of analysis pipelines for Phase I-III trials. Recognised for optimising datasets for regulatory submissions and mentoring junior programmers on best practices.
Skills
- SAP
- SQL
- Statistical Analysis
- GO
- SAS
- Data Visualisation
- Clinical Trial Design
Experience
Senior Statistical Programmer — Cytel
- Architected automated reporting pipelines that reduced analysis turnaround from 10 days to 3 days across 5 Phase II trials.
- Implemented a reusable library of SAS macros adopted by 15 programmers for consistent analysis outputs and reduced validation errors.
- Mentored 6 junior programmers on CDISC standards, improving submission readiness of datasets for FDA and EMA review.
- Designed interactive visualisation dashboards for project stakeholders, enhancing decision-making with real-time trial progress data.
- Partnered with biostatisticians to translate complex statistical models into executable analysis plans, maintaining 100% protocol compliance.
Statistical Programmer — IQVIA
- Developed analysis datasets for 12 Phase III trials, maintaining 99% accuracy through rigorous QC processes and automated validation checks.
- Reduced ad-hoc analysis turnaround from 2 weeks to 3 days by implementing templated SAS programmes and stakeholder collaboration norms.
- Conducted training sessions on CDISC standards and SAS best practices, elevating data standards across 20+ clinical projects.
- Created interactive R Shiny dashboards for real-time monitoring of key efficacy and safety endpoints, facilitating timely data reviews.
- Supported regulatory submissions by preparing annotated datasets and analysis plans that satisfied FDA inspection requirements.
Senior Statistical Programmer — Valos Srl
- Led statistical programming for 8 Phase I-II oncology trials, delivering analysis datasets on schedule for interim safety reviews.
- Automated weekly safety monitoring reports used by cross-functional teams, reducing manual compilation time by 75%.
- Partnered with biostatistics to publish findings in peer-reviewed journals, translating complex models into clear analysis deliverables.
- Mentored 4 entry-level programmers, establishing coding standards and review processes that improved submission readiness.
- Created SAS macros that streamlined dataset derivations, cutting programming time on new studies by 30%.
Education
M.S. Computer Science
Stanford University
Certifications
- SAS Certified Advanced Programmer
- CDISC Certified Professional