Associate Principal Scientist Statistical Programming, Submission Data Standards Quality Management (Hybrid)
Core
Oversees quality management of submission data standards for worldwide regulatory applications of drug and vaccine clinical development projects.
Role type
Associate Principal Statistical Programmer (Submission Data Standards Quality Management)
Builds
Electronic submission deliverables compliant with CDISC standards (SDTM, ADaM, Define-XML, SDRG, ADRG) for FDA, EMA, and PMDA.
Domain
Life Sciences / Clinical Trials / Regulatory Submissions
Required skills
SAS programming, CDISC standards (SDTM, ADaM), regulatory submission planning, stakeholder management, technical writing, project management, data mapping, clinical data standardization
Preferred skills
GenAI/automation application, metadata repository management, process improvement, Microsoft Project, global coordination, standards governance forums
Technologies
Pinnacle 21 Enterprise, SDTM, ADaM, Define-XML, SDRG, ADRG, Microsoft Project
Responsibilities
Prepare PreNDA/PreBLA meetings and FDA e-data mailbox questions; guide teams on submission deliverables using Pinnacle 21; manage up-versioning of SDTM standards; participate in industry best practice teams; serve as statistical programming point of contact.
Seniority
Senior, hands-on IC with strategic oversight (via careerplan.io/jobs/R420678-1-associate-principal-scientist-statistical-programming-submission-data-standards-quality-ma)