Staffana · 1 week ago
Clinical Data Scientist – RBQM
Staffana is a company that supports Clinical Development and Medical Affairs through data science. The RBQM Data Scientist is responsible for centralized monitoring and risk-based quality management activities for clinical trials, focusing on implementing and executing predefined risk metrics and delivering scalable analytics.
Outsourcing/Offshoring
Responsibilities
Implement and maintain predefined KRIs, QTLs, and triggers using robust, reusable SAS programs and macros
Extract, transform, and integrate data from EDC systems (e.g., RAVE) and other clinical data sources into analysis-ready datasets
Produce routine and ad-hoc RBQM outputs (tables, listings, data extracts, dashboard feeds) for signal detection and study review
Perform QC, validation, and troubleshooting of SAS code to ensure accuracy and efficiency
Maintain complete technical documentation (specs, validation records, change logs)
Collaborate cross-functionally with Central Monitors, Central Statistical Monitoring, Data Management, Biostatistics, and Study Operations
Qualification
Required
PhD, MS, or BS in Statistics, Biostatistics, Computer Science, Data Science, Life Sciences, or related field
Relevant clinical development experience (programming, RBQM/RBM, Data Management): 1. PhD: 3+ years 2. MS: 5+ years 3. BS: 8+ years
Advanced SAS programming in a clinical trials environment (Base SAS, Macros, SAS SQL)
Hands-on experience with clinical trial datasets
Proficiency in MS Word, Excel, and PowerPoint
Knowledge of GCP, ICH, FDA guidance, and RBQM/RBM concepts
Strong analytical and problem-solving skills
Effective communication and collaboration in global, cross-functional teams
Ability to manage multiple programming deliverables in a fast-paced environment
Preferred
Experience with RAVE EDC
Knowledge of CDISC/CDASH/SDTM standards
Exposure to R, Python, JavaScript, or clinical data visualization tools
Company
Staffana
Staffana helps growing firms reach their full potential by allowing them to develop highly trained global teams in days rather than months.
Funding
Current Stage
Early StageCompany data provided by crunchbase