- Company Name
- TALENT Software Services
- Job Title
- Data Scientist
- Job Description
-
**Job title**
Data Scientist – Risk‑Based Quality Management (RBQM)
**Role Summary**
Design, implement, and maintain SAS‑based analytics for risk‑based monitoring across multiple clinical trials. Translate data from EDC/RAVE and other sources into analysis‑ready datasets, create reports, dashboards, and monitoring outputs to support signal detection and quality risk management.
**Expectations**
Deliver robust, scalable SAS programs that run pre‑defined Key Risk Indicators (KRIs), Quality Trigger Levels (QTLs), and triggers. Provide accurate, well‑documented code, collaborate with cross‑functional teams, and ensure outputs meet regulatory and quality standards.
**Key Responsibilities**
- Develop and maintain SAS Base, Macro, and SQL programs for KRIs, QTLs, and other risk metrics.
- Extract, transform, and load (ETL) data from EDC systems (e.g., RAVE) and other clinical data sources into SAS datasets.
- Generate routine and ad‑hoc RBQM/central monitoring outputs (tables, listings, dashboards).
- Perform QA/QC on SAS code and outputs, troubleshoot performance issues.
- Produce and maintain technical documentation (specifications, validation records, change logs).
- Work with Central Monitors, Statisticians, Data Management, Biostatistics, and Operations to translate requirements into analytic solutions.
- Support data visualization and reporting tools as needed.
**Required Skills**
- Advanced SAS programming (Base, Macro, SQL) in a clinical trials environment.
- Experience with large, complex clinical datasets and EDC/SDTM data.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Familiarity with RAVE EDC, CDISC/CDASH/SDTM standards.
- Ability to document SOPs, validation, and change control.
- Strong analytical, problem‑solving, and communication skills.
**Required Education & Certifications**
- PhD, MS, or BA/BS in Statistics, Biostatistics, Computer Science, Data Science, Life Science, or related field.
- Clinical development experience: PhD 3+ yrs, MS 5+ yrs, BA/BS 8+ yrs.
- Knowledge of GCP, ICH, FDA guidance (preferred).
- Practical experience with R, Python, or JavaScript and clinical data visualization tools is a plus.