Sr. Scientist, Stat. Programming - SDTM (Hybrid)

Responsibilities Provide oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions for drug and vaccine clinical development projects. Plan submission data standards activities; coach and consult project teams; engage external vendors/partners. Support continuous improvement of the electronic submission process with tools/templates focusing on traceability, QA, data conformance, and data fitness. Collaborate with statistical programming, statistics, regulatory, and other stakeholders. Primary Activities Prepare for PreNDA/PreBLA meetings; develop study data standards plans; prepare questions for FDA e-data mailboxes (CBER/CDER); attend meetings with FDA/EMA/PMDA. Guide teams preparing submission deliverables (including Pinnacle 21 Enterprise). Up-version activities to specific SDTM versions. Participate in industry teams/conferences; serve on departmental strategic initiative project teams. Education and Minimum Requirements BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or related field + 5 years SAS programming experience in a clinical trial environment. MS in related field + 3 years SAS programming experience in a clinical trial environment. Required Skills/Experience Interpersonal skills; negotiation/collaboration. Written/oral/presentation skills. Experience developing R&D analysis/reporting deliverables (data, analyses, tables, graphics, listings). Ability to lead projects independently and collaborate with stakeholders. Drug/vaccine regulatory submission experience, including electronic submission deliverables. CDISC standards (SDTM, ADaM), Define.XML, cSDRG, ADRG; ensure deliverable quality and process compliance. Technical writing; translate complex ideas into clear content. Project management; clinical data management knowledge; strategic thinking; anticipate stakeholder requirements. Preferred Skills Hands‑on R and Python. Reporting processes (SOPs) and SDLC knowledge. Consistency across protocols/projects; work across cultures/geographies. Manage deliverables with global outsource programming staff. Experience developing/managing project plans (Microsoft Project or similar); professional society activity; process improvement. #J-18808-Ljbffr Scorpion Therapeutics