Data Scientist

Data Scientist

Location: Remote

Duration 4-6 months

Advanced SAS programming (Base, Macro, SQL) in clinical trials with RBQM/RBM experience, hands-on clinical data analysis (KRIs/QTLs), EDC data integration (RAVE preferred), strong QC/documentation, and cross-functional collaboration skills.

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.

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.