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The RBQM Data Scientist supports central monitoring and risk-based quality management (RBQM) for clinical trials. This role focuses on implementing and running pre-defined KRIs, QTLs, and other risk metrics using clinical data, with strong emphasis on SAS programming to deliver robust and scalable analytics across multiple studies.
Job Responsibility:
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
Requirements:
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: PhD: 3+ years, MS: 5+ years, BA/BS: 8+ years
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
Knowledge of GCP, ICH, FDA guidance related to clinical trials and risk-based monitoring
Strong analytical and problem-solving skills
ability to interpret complex data and risk outputs
Effective communication and teamwork skills
comfortable collaborating with cross-functional, global teams
Ability to manage multiple programming tasks and deliver high-quality work in a fast-paced environment
Nice to have:
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
What we offer:
Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans