✦ Luna Orbit — Data & Analytics

Senior Manager - Data Standards (Hybrid)

at AbbVie

📍 Irvine, CA Hybrid Posted March 29, 2026
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Position Details

Type Full-Time
Experience senior
Exp. Years MS with 9 years of relevant clinical research experience, or BS with 11 years of relevant clinical research experience
Education MS with 9 years of relevant clinical research experience, or BS with 11 years of relevant clinical research experience
Category Data & Analytics

About this role

Senior Manager in Clinical Data and Reporting Standards develops and governs CDISC data and reporting standards for AbbVie’s clinical trials, ensuring conformance to CDISC standards and regulatory requirements.

Key Responsibilities

  • Lead or participate in a cross-functional team of subject matter experts to define standards within the assigned therapeutic area: Data Collection, Data Review Rules, SDTM mapping, ADaM mapping and derivation, Study-level tables, listings, or figures, Product-level safety analysis displays
  • Ensure each standard is clearly defined, with documentation of relevant assumptions and decisions related to its use
  • Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer's Guides for FDA and PMDA submissions
  • Consult on conformance issues for SDTM and/or ADaM and work with the study team to resolve issues
  • Represent AbbVie's interests in industry standards development projects; stay current with industry standards such as CDISC, regulatory requirements, and drive improvements to completion

Technical Overview

Leads SDTM/ADaM standard development, SDTM define.xml, annotated CRF, and guidance for FDA/PMDA submissions; uses SAS or R for data processing and standardization.

Ideal Candidate

The ideal candidate is a senior data standards professional with 9+ years of experience in clinical data standards, CDISC, and regulatory submissions, able to lead governance across AbbVie’s clinical data lifecycle.

Must-Have Skills

Experience leading development of standards for data collectiontabulationanalysis and/or reportingExperience with at least two of the following standards: CDASHSDTMADaMAnalysis Results Metadataor TLF standardsExperience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions

Nice-to-Have Skills

Active participation in CDISC teamsSAS or R programming experienceExperience creating SDTM specifications or training others to use SDTM

Tools & Platforms

SASR

Required Skills

CDISC StandardsCDASHSDTMADaMData Collection standardsData Review RulesSDTM mappingADaM mapping and derivationStudy-level tablesCRF designdefine.xmlRegulatory submissionsFDA submissionsPMDA submissionsSDTM datasetsADaM datasetsSASR

Hard Skills

CDISC StandardsCDASHSDTMADaMCRF designdefine.xmlClinical Study Data Reviewer's GuidesFDA submissionsPMDA submissionsSASR

Soft Skills

Cross-Functional CollaborationCommunicationTraining & EducationDocumentationProblem Solving

Industry & Role

Industry Healthcare & Medical
Job Function Develop and govern clinical data and reporting standards (CDISC) for regulatory submissions and trial governance
Role Subtype Strategy & Advisory
Tech Domains SAS, R, CDISC Standards, SDTM, ADaM, CDASH

Keywords for Your Resume

CDISCCDASHSDTMADaMCDISC StandardsCRF designdefine.xmlClinical Study Data Reviewer's GuidesFDA submissionsPMDA submissionsSASR programmingSDTM datasetsADaM datasetsRegulatory submissionsCDISC teamsSAS or R programming experienceSDTM specificationsregulatory submissions

Deal Breakers

Lack of CDISC/CDASH/SDTM/ADaM experience, No SAS or R programming experience

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