Sr. Scientist, Stat. Programming - SDTM (Hybrid)
Merck
5 hours ago
Remote friendly (North Wales, PA)
United States
Clinical Research and Development
Responsibilities:
- Provide oversight and quality management of submission data standards deliverables for worldwide regulatory drug and vaccine clinical development submissions.
- Lead submission data standards planning, coach/consult project teams, coordinate with external vendors/partners, and maintain current knowledge of industry standards (e.g., SDTM, ADaM, clinical site data for CDER inspection planning).
- Drive continuous improvement of the electronic submission process; provide tools/templates supporting traceability, QA, data conformance, and data fitness.
- Collaborate with statistical programming, statistics, regulatory, and other project stakeholders.
Primary Activities:
- Prepare for PreNDA/PreBLA meetings, develop study data standards plans, submit questions to FDA e-data mailboxes (CBER/CDER), and attend regulatory meetings (FDA, EMA, PMDA).
- Guide teams preparing submission deliverables using Pinnacle 21 Enterprise.
- Perform up-versioning activities to specific SDTM versions.
- Participate in industry best-practice teams/conferences and departmental strategic initiative projects.
Education & Minimum Requirements:
- BA/BS in CS, Statistics, Applied Math, Life Sciences, Engineering (or related) + 5 years SAS programming in a clinical trial environment.
- OR MS in the same fields + 3 years SAS programming in a clinical trial environment.
Required Skills/Experience:
- Interpersonal/negotiation and collaboration skills; strong written/oral/presentation skills.
- Experience developing analysis and R&D reporting deliverables (data, analyses, tables, graphics, listings).
- Ability to lead projects independently at a project level and collaborate with stakeholders.
- Drug/vaccine regulatory submission experience; development of electronic submission deliverables.
- CDISC experience (SDTM, ADaM), Define.XML, cSDRG, ADRG; demonstrated deliverable quality and process compliance.
- Strong technical writing; solid project management; clinical data management familiarity.
- Strategic thinking, stakeholder anticipation, and turning strategy into tactical execution.
Preferred Skills:
- R and Python for data analysis/statistical modeling; strong SOP/SDLC knowledge.
- Consistency across protocols/projects; work across cultures/geographies.
- Delivering programming with global outsource partners; Microsoft Project (or similar) project planning.
- Professional society involvement; process improvement experience.
Application instructions: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
- Provide oversight and quality management of submission data standards deliverables for worldwide regulatory drug and vaccine clinical development submissions.
- Lead submission data standards planning, coach/consult project teams, coordinate with external vendors/partners, and maintain current knowledge of industry standards (e.g., SDTM, ADaM, clinical site data for CDER inspection planning).
- Drive continuous improvement of the electronic submission process; provide tools/templates supporting traceability, QA, data conformance, and data fitness.
- Collaborate with statistical programming, statistics, regulatory, and other project stakeholders.
Primary Activities:
- Prepare for PreNDA/PreBLA meetings, develop study data standards plans, submit questions to FDA e-data mailboxes (CBER/CDER), and attend regulatory meetings (FDA, EMA, PMDA).
- Guide teams preparing submission deliverables using Pinnacle 21 Enterprise.
- Perform up-versioning activities to specific SDTM versions.
- Participate in industry best-practice teams/conferences and departmental strategic initiative projects.
Education & Minimum Requirements:
- BA/BS in CS, Statistics, Applied Math, Life Sciences, Engineering (or related) + 5 years SAS programming in a clinical trial environment.
- OR MS in the same fields + 3 years SAS programming in a clinical trial environment.
Required Skills/Experience:
- Interpersonal/negotiation and collaboration skills; strong written/oral/presentation skills.
- Experience developing analysis and R&D reporting deliverables (data, analyses, tables, graphics, listings).
- Ability to lead projects independently at a project level and collaborate with stakeholders.
- Drug/vaccine regulatory submission experience; development of electronic submission deliverables.
- CDISC experience (SDTM, ADaM), Define.XML, cSDRG, ADRG; demonstrated deliverable quality and process compliance.
- Strong technical writing; solid project management; clinical data management familiarity.
- Strategic thinking, stakeholder anticipation, and turning strategy into tactical execution.
Preferred Skills:
- R and Python for data analysis/statistical modeling; strong SOP/SDLC knowledge.
- Consistency across protocols/projects; work across cultures/geographies.
- Delivering programming with global outsource partners; Microsoft Project (or similar) project planning.
- Professional society involvement; process improvement experience.
Application instructions: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).