Associate Principal Scientist Statistical Programming, Submission Data Standards Quality Management (Hybrid)
$142.4k - $224.1kMerck
Associate Principal Scientist role overseeing submission data standards quality management for regulatory drug and vaccine applications. Provides leadership on CDISC standards implementation, coaches project teams, and ensures compliance with FDA submission requirements across global clinical development programs.
Responsibilities
- Oversee quality management and compliance of submission data standard deliverables for regulatory applications
- Prepare PreNDA/PreBLA meetings, study data standards plans, and FDA correspondence including e-data mailbox questions
- Guide project teams on submission deliverables preparation and Pinnacle 21 Enterprise tool usage
- Lead SDTM version-up activities and participate in industry standards best practice forums
- Serve as statistical programming point of contact and knowledge holder for assigned projects
Requirements
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, or Engineering plus 9 years SAS programming in clinical trials, OR MS in related field plus 7 years SAS experience
- Leadership-level experience with US and/or worldwide drug/vaccine regulatory submission and electronic deliverables
- Strong knowledge of CDISC standards including SDTM, ADaM, Define-XML, SDRG, and ADRG
- Expertise in SDTM standards application, controlled terminology, clinical data standardization, and issue resolution
- Excellent interpersonal, written, oral, and presentation skills with strong project management abilities
- Technical proficiency in clinical data management processes and their relationship to submission deliverables
- Strategic thinking capability translating standards into practical processes and implementation approaches
Vacancy posted 12 days ago
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