Senior Scientist, Statistical Programming, SDTM (Hybrid)
Core
Oversees quality management of submission data standards for global regulatory applications of drug and vaccine clinical development projects.
Role type
Senior Statistical Programmer (Submission Data Standards Quality Management)
Builds
Electronic submission deliverables compliant with CDISC standards for FDA, EMA, and PMDA
Domain
Life Sciences / Clinical Trials / Regulatory Submissions
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
SAS programming, CDISC standards (SDTM, ADaM, Define.XML), regulatory submission planning, project management, technical writing, data conformance assurance
Preferred skills
Python, R, process improvement, global outsource partner management, Microsoft Project
Technologies
Pinnacle 21 Enterprise, Microsoft Project, SAS
Responsibilities
Prepare PreNDA/PreBLA meeting materials and study data standards plans, guide project teams on submission deliverables, attend regulatory agency meetings, maintain industry standards knowledge, drive continuous improvement of electronic submission processes
Seniority
Senior, hands-on IC with strategic oversight
