Associate Principal Scientist, Statistical Programming, Submission Data Standards, Quality Management

MSD

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

Posted 10/6/2026full-timeUnited StatesSeniorLead💰 $142,400 - $224,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in SAS Programming and a strong understanding of CDISC submission standards, including SDTM and ADaM. Capable of leading regulatory submission processes and collaborating effectively with cross-functional teams to ensure high-quality deliverables.

Highest-signal resume keywords

SAS Programming ExperienceCDISC Submission StandardsSDTM and ADaM ExpertiseProject Management SkillsRegulatory Submission Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

SAS ProgrammingSDTM StandardsADaM StandardsData MappingClinical Data StandardizationAnalysis and Reporting DeliverablesProcess ImprovementTechnical GuidanceData ConformanceQuality Assurance

Soft Skills

Interpersonal SkillsNegotiation SkillsCollaboration SkillsStrategic ThinkingTechnical Writing Skills

Tools & Technologies

Pinnacle 21 EnterpriseMicrosoft ProjectGenAIAutomation TechnologiesAdvanced Analytics Technologies

Industry Keywords

Regulatory Application SubmissionClinical DevelopmentFDAEMAPMDAClinical Trial EnvironmentSubmission Data StandardsStakeholder ManagementStandards GovernanceMetadata Repositories

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Provide oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions of drug and vaccine clinical development projects
Lead submission data standards planning activities
Coach and consult project teams
Conduct outreach to 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 the electronic submission process
Provide tools and templates supporting traceability, quality assurance, data conformance, and data fitness
Collaborate with statistical programming, statistics, regulatory, and other project stakeholders
Ensure project plans are executed efficiently with timely, high-quality deliverables
Serve as statistical programming point of contact and knowledge holder for assigned projects
Prepare for PreNDA and PreBLA meetings and develop study data standards plans
Prepare questions for FDA e-data mailboxes and attend FDA, EMA, and PMDA regulatory meetings
Guide project teams preparing submission deliverables using Pinnacle 21 Enterprise
Perform SDTM up-versioning activities
Participate in industry teams and conferences on best practices
Serve on 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 a minimum of 9 years SAS programming experience in a clinical trial environment; or MS in one of these fields plus a minimum of 7 years SAS programming experience in a clinical trial environment
US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level, including development of electronic submission deliverables
Strong knowledge and practical experience with CDISC submission standards, including SDTM and ADaM, and Define-XML, SDRG, and ADRG
Strong working knowledge of SDTM standards, controlled terminology, and clinical data standardization
Experience providing technical guidance and leadership related to SDTM standards, data mapping, implementation, and issue resolution
Excellent interpersonal, negotiation, collaboration, written, oral, presentation, and technical writing skills
Broad knowledge and significant experience developing analysis and reporting deliverables for R&D projects
Strong project management, organizational, stakeholder management, and strategic thinking skills
Working knowledge of clinical data management and clinical development processes and their relationship to SDTM and downstream submission deliverables
Ability to translate strategy into practical standards, processes, and implementation
Experience applying GenAI, automation, and advanced analytics technologies is preferred
Experience with standards governance forums, metadata repositories, standards libraries, mapping solutions, process improvement, reporting processes, SOPs, SDLC, and Microsoft Project or similar is preferred
Active participation in professional societies is preferred
VISA Sponsorship: Yes

Benefits

Comp & perks

Annual bonus
Long-term incentive, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate days
Sick days
Visa sponsorship
Hybrid work arrangement
10% travel requirement
Domestic relocation