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

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.

• 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.

• 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). For PhD: 3+ years;
  For MS: 5+ years;
  For 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.

• 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 GCP, ICH, and FDA guidance related to clinical trials and risk-based monitoring.

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.