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About
KEY RESPONSIBILITIES: The RBQM Data Scientist may perform a range of the following responsibilities, depending upon the studies' complexity and studies' development stage: • Implement and maintain pre-defined KRIs, QTLs, and triggers using robust SAS programs/macros across multiple clinical studies. • Extract, transform, and integrate data from EDC systems (e.g., RAVE) and other clinical sources into analysis-ready SAS datasets. • Run routine and ad-hoc RBQM/central monitoring outputs (tables, listings, data extracts, dashboard feeds) to support signal detection and study review. • Perform QC and troubleshooting of SAS code; ensure outputs are accurate and efficient. • Maintain clear technical documentation (specifications, validation records, change logs) for all RBQM programs and processes. • Collaborate with Central Monitors, Central Statistical Monitors, Data Management, Biostatistics, and Study Operations to understand requirements and ensure correct implementation of RBQM metrics.
Qualifications Education & Experience • PhD, MS, or BA/BS in statistics, biostatistics, computer science, data science, life science, or a related field. • Relevant clinical development experience (programming, RBM/RBQM, Data Management), for example: o PhD: 3+ years o MS: 5+ years o BA/BS: 8+ years
Technical - Required • Advanced SAS programming skills (hard requirement) in a clinical trials environment (Base SAS, Macro, SAS SQL; experience with large, complex clinical datasets). • Hands-on experience working with clinical trial data. • Proficiency with Microsoft Word, Excel, and PowerPoint. Technical - Preferred / Strong Plus • Experience with RAVE EDC. • Awareness or working knowledge of CDISC, CDASH, SDTM standards. • Exposure to R, Python, or JavaScript and/or clinical data visualization tools/platforms.
Languages
- English
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