What are the responsibilities and job description for the Data Architect – SDTM position at Silicontek Inc?
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
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
- 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