Senior Scientist, Statistical Programming – SDTM

MSD

. Provide oversight and quality management of submission data standard deliverables for worldwide regulatory applications involving drug and vaccine clinical development projects .

Posted 11/11/2026full-timeUnited StatesSenior💰 $117,000 - $184,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submission processes and data standards, particularly CDISC standards such as SDTM and ADaM, while effectively collaborating with cross-functional teams and stakeholders. Proven ability to manage quality assurance and compliance in electronic submission deliverables for drug and vaccine clinical development.

Highest-signal resume keywords

SAS Programming ExperienceCDISC StandardsRegulatory Submission ExperienceProject Management SkillsTechnical Writing Ability

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

SAS ProgrammingCDISC StandardsData ManagementData ModelingNumerical AnalysisSDTMADaMDefine.XMLCSDRGADRG

Soft Skills

Interpersonal SkillsNegotiation SkillsCollaboration SkillsWritten Communication SkillsPresentation Skills

Tools & Technologies

Pinnacle 21 Enterprise

Industry Keywords

Regulatory ApplicationsClinical DevelopmentElectronic SubmissionQuality AssuranceStakeholder Relationship ManagementClinical Data ManagementFDAEMAPMDAContinuous Improvement

About the role

Key responsibilities & impact

Provide oversight and quality management of submission data standard deliverables for worldwide regulatory applications involving drug and vaccine clinical development projects
Lead submission data standards planning, coach and consult project teams, and engage external vendors and partners
Maintain current knowledge of industry submission data standards, including SDTM, ADaM, and clinical site data for CDER inspection planning
Drive continuous improvement of electronic submission processes and provide tools and templates supporting traceability, quality assurance, data conformance, and data fitness
Collaborate with statistical programming, statistics, regulatory, and other project stakeholders
Prepare for PreNDA and PreBLA meetings and study data standards plans
Prepare questions for FDA e-data mailboxes and attend FDA, EMA, and PMDA meetings
Guide project teams preparing submission deliverables using Pinnacle 21 Enterprise
Perform up-versioning activities for specific SDTM versions
Participate in industry teams, conferences, and departmental strategic initiative project teams

Requirements

What you’ll need

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment, OR MS in one of these fields plus 3 years SAS programming experience in a clinical trial environment
Effective interpersonal, negotiation, collaboration, written, oral, and presentation skills
Knowledge and experience developing analysis and reporting deliverables for R&D projects
Ability to complete tasks independently at a project level and collaborate with key stakeholders
US and/or worldwide drug or vaccine regulatory application submission experience, including electronic submission deliverables
Experience with CDISC submission standards: SDTM, ADaM, Define.XML, cSDRG, ADRG
Demonstrated success assuring deliverable quality and process compliance
Technical writing ability
Project management skills
Familiarity with clinical data management concepts
Strategic thinking and ability to turn strategy into tactical activities
Ability to anticipate stakeholder requirements
No visa sponsorship available
Must be a US or Puerto Rico resident
Required skills: CDISC Standards, Data Management, Data Modeling, Numerical Analysis, Stakeholder Relationship Management, SDTM, Waterfall Model

Benefits

Comp & perks

Annual bonus and long-term incentive, if applicable
Medical, dental, vision healthcare and other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Hybrid work arrangements