Senior Data Analyst

SME/Data Analyst with deep knowledge of Clinical data standards(SDTM) 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 Core Technical Expertise Required • 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, Especially CDISC Standards • Deep knowledge of SDTM (Study Data Tabulation Model) including: • 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) Ideal Profile • 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 Skills: sdtm,clinical data,data