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
- 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