System One
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). 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.
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 GCP, 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.
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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). 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.
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 GCP, 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.
#J-18808-Ljbffr