Data Architect – SDTM

Data Architect SDTM

Location: Onsite, Alameda, CA (Near Oakland Airport)

The SME should have strong experience working in clinical IT environments with a strong business-facing orientation, closely partnering with stakeholders across Biostatistics, Statistical Programming, Clinical Operations, and Clinical Data Management.

This role requires deep hands-on expertise in clinical data standards and regulatory submission datasets, with frequent collaboration with Biostatistics teams to ensure high-quality downstream analysis-ready data.

Key Responsibilities & Collaboration Areas

• Work closely with Biostatistics teams to support study design, analysis readiness, and submission data strategy
• Partner with Statistical Programmers to ensure correct implementation of analysis datasets
• Collaborate with Clinical Data Managers (CDM) to ensure source data aligns with downstream SDTM requirements
• Interface with Clinical Operations (Clin Ops) to ensure operational data capture supports analysis needs Act as a bridge between IT systems/data architecture and clinical study execution teams

Core Technical Expertise Required

• Strong expertise in CDISC standards
• Deep knowledge of SDTM (Study Data Tabulation Model)
• Domain structures and mapping from raw clinical data
• Controlled terminology and implementation guidelines
• Submission-ready SDTM datasets
• Strong understanding of ADaM (Analysis Data Model):
• Dataset creation for statistical analysis
• Traceability from SDTM ADaM TLFs (Tables, Listings, Figures)
• Experience with SDTM domain mapping specifications and transformation logic
• Familiarity with regulatory submission expectations (e.g., FDA/PMDA)
• Proven experience working in clinical trial data environments
• Hands-on exposure to SDTM and ADaM dataset creation or review
• Strong ability to translate between Clinical/business requirements
• Statistical analysis needs
• Technical data structures
• Comfortable engaging in deep technical discussions with biostatisticians
• Ability to act as a translation layer between IT/data systems and scientific teams