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.