SME / Data Analyst

🚨 We're Hiring | SME / Data Analyst (Clinical Data Standards - SDTM & ADaM) 📍 Location: Remote 📅 Experience: 10+ Years We are looking for an experienced SME / Data Analyst with deep expertise in Clinical Data Standards (SDTM & ADaM) to support clinical data initiatives in a regulated clinical trial environment. Key Responsibilities: ✅ Partner with Biostatistics, Statistical Programming, Clinical Data Management, and Clinical Operations teams. ✅ Ensure high-quality, submission-ready clinical datasets. ✅ Collaborate on study design, analysis readiness, and regulatory submission strategy. ✅ Bridge business, scientific, and IT teams by translating clinical requirements into technical data solutions. ✅ Support SDTM implementation, ADaM dataset development, and regulatory compliance. Required Skills: ✔ 10+ years of experience in Clinical Data Management/Data Analytics. ✔ Strong expertise in CDISC Standards (SDTM & ADaM). ✔ Experience with SDTM domain mapping, transformation logic, and controlled terminology. ✔ Understanding of traceability from SDTM → ADaM → TLFs. ✔ Familiarity with FDA/PMDA regulatory submission requirements. ✔ Experience working with Biostatistics, Statistical Programming, Clinical Operations, and Clinical Data Management teams. ✔ Excellent stakeholder communication and business analysis skills. Ideal Candidate: • Extensive experience in clinical trial data environments. • Hands-on experience creating or reviewing SDTM and ADaM datasets. • Ability to translate clinical, statistical, and technical requirements into effective data solutions. • Comfortable collaborating with scientific and technical stakeholders.