Sr. Scientist, Stat. Programming - SDTM (Hybrid)
Merck
11 days ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
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.
- 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.