(CW) Data Scientist

Job Title: Data Scientist, RBQM (Clinical Trials)
Location: Novato, CA
Hours/Schedule: Monday-Friday, 8 am to 5 pm
Compensation: $72.00-$79.00 hourly, DOQ
Type: Contract

**We cannot work C2C with any other agency - must be US based**
Overview
The Data Scientist, RBQM supports central monitoring and risk-based quality management activities for clinical trials by delivering robust, SAS-driven analytics across multiple studies. This role partners closely with Data Management, Biostatistics, and Clinical Operations to implement key risk indicators and ensure high-quality, analysis-ready clinical data.
Responsibilities

• Implement and maintain pre-defined KRIs, QTLs, and triggers using scalable SAS programs and macros across clinical studies.
• Extract, transform, and integrate data from EDC systems and other clinical data sources into analysis-ready datasets.
• Produce routine and ad hoc RBQM and central monitoring outputs, including tables, listings, extracts, and dashboard feeds.
• Perform quality control, validation, and troubleshooting of SAS programs to ensure accuracy and efficiency.
• Maintain technical documentation, including specifications, validation records, and change logs.
• Collaborate with Central Monitoring, Data Management, Biostatistics, and Study Operations to clarify requirements and ensure correct implementation of RBQM metrics.
• Support data-driven signal detection and study oversight activities throughout the clinical trial lifecycle.

Qualifications Must Have

• PhD, MS, or BA/BS in statistics, biostatistics, computer science, data science, life sciences, or a related field.
• Relevant clinical development experience (programming, RBM/RBQM, or Data Management):
  
• PhD: 3+ years
• MS: 5+ years
• BA/BS: 8+ years

Advanced SAS programming expertise in a clinical trials environment (Base SAS, Macro, SAS SQL).

Hands-on experience working with large, complex clinical trial datasets.

Proficiency with Microsoft Word, Excel, and PowerPoint.
Nice to Have

• Experience with RAVE EDC.
• Working knowledge of CDISC standards, including CDASH and SDTM.
• Exposure to R, Python, or JavaScript.
• Experience with clinical data visualization tools or platforms.
• Knowledge of Google Cloud Platform, ICH, and FDA guidance related to clinical trials and risk-based monitoring.

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Ref: #568-Clinical