✦ Luna Orbit — Data & Analytics

Associate Principal Scientist, Stat. Programming - SDTM (Hybrid)

at Merck

📍 USA - Pennsylvania - North Wales (Upper Gwynedd) Hybrid 💰 $142K – $224K USD / year Posted March 31, 2026
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Position Details

Salary $142K – $224K USD / year
Type Full-Time
Experience senior
Exp. Years 7+ years
Education BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field; plus 9 or more years SAS programming experience in a clinical trial environment OR MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field; plus 7 or more years SAS programming experience in a clinical trial environment.
Category Data & Analytics

About this role

Associate Principal Statistical Programmer will oversee submission data standards quality for world-wide regulatory submissions, guiding SDTM/ADaM deliverables and up-versioning data standards, with hands-on SAS and Python development and collaboration across regulatory and project stakeholders.

Key Responsibilities

  • Oversee submission data standards quality
  • Guide project teams on SDTM/ADaM deliverables with Pinnacle 21 Enterprise
  • Up-versioning SDTM versions
  • Develop SAS Macros and Python functions for SDTM conversions
  • Prepare for PreNDA/PreBLA meetings with regulatory agencies

Technical Overview

Role requires strong SAS programming, Python development, and CDISC submission standards (SDTM/ADaM), with experience using Pinnacle 21 Enterprise and Define.XML for regulatory submissions. Emphasis on quality assurance, traceability, and cross-functional project leadership.

Ideal Candidate

The ideal candidate is a senior statistical programmer with 7+ years in clinical trial SAS programming, deep expertise in SDTM/ADaM and CDISC standards, and a track record delivering regulatory submission deliverables. They should be adept at leading cross-functional teams, coaching others, and driving data standards quality across global projects.

Must-Have Skills

SAS programmingSASCDISC (SDTMADaM)Pinnacle 21 EnterprisePythonRegulatory submissionsProject ManagementTraceabilityQuality AssuranceData Standards

Nice-to-Have Skills

Microsoft ProjectSOPsSDLCMentoringGlobal outsourcing managementProcess improvementSAS Macro developmentCross-cultural collaboration

Tools & Platforms

Pinnacle 21 EnterpriseSASPythonCDISC Define.XMLMicrosoft Project

Required Skills

AccountabilityClinical TrialsComputer ProgrammingComputer ScienceData AnalysisData ManagementData ModelingMachine Learning (ML)Microsoft ProjectNumerical AnalysisProcess ImprovementsProject ManagementProject PlanningRegulatory ComplianceSoftware DevelopmentStakeholder Relationship ManagementStatistical ProgrammingStrategic ThinkingWaterfall ModelSASPythonCDISCSDTMADaMDefine.XMLSDRGADRGPinnacle 21 EnterprisePreNDAPreBLA

Hard Skills

SAS programmingSASPythonSDTMADaMCDISCDefine.XMLPinnacle 21 EnterpriseMicrosoft ProjectPreNDAPreBLAData StandardsQuality AssuranceTraceabilityData ConformanceRegulatory SubmissionsRegulatory Compliance

Soft Skills

Interpersonal skillsNegotiationCollaborationWritten and verbal communicationPresentation skillsLeadership

Industry & Role

Industry Healthcare & Medical
Job Function Lead data standards quality and regulatory submission programming for SDTM/ADaM in BARDS.
Role Subtype data analytics lead

Clearance & Visa

Visa Sponsorship Yes

Keywords for Your Resume

AccountabilityClinical TrialsComputer ProgrammingComputer ScienceData AnalysisData ManagementData ModelingMachine Learning (ML)Microsoft ProjectNumerical AnalysisProcess ImprovementsProject ManagementProject PlanningRegulatory ComplianceSoftware DevelopmentStakeholder Relationship ManagementStatistical ProgrammingStrategic ThinkingWaterfall ModelSASPythonCDISCSDTMADaMPinnacle 21 EnterpriseDefine.XMLRegulatory SubmissionsPreNDAPreBLAQuality AssuranceData StandardsTraceabilitySAS programmingRegulatory submissions

Deal Breakers

No regulatory submission experience, Lack of SAS programming experience in clinical trials, Not eligible to work in the US

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