Manager, Clinical Data & Reporting Standards - SDTM Programming (Hybrid)

Irvine, CA, United Statesfull time

On Site

senior

H1B: yes

AbbVie The Manager, Clinical Data and Reporting Standards leads development and governance of clinical data standards including SDTM programming to support AbbVie's clinical trials. This role ensures compliance with CDISC standards and oversees SDTM dataset creation and regulatory submissions.

Responsibilities

Participate with cross-functional teams to define data collection, data review rules, SDTM mapping, ADaM mapping, study-level tables, and safety analysis displays standards
Ensure standards are clearly defined with appropriate documentation
Ensure consistency across standard types
Develop training materials on proper use of standards
Communicate ongoing standard development activities
Provide feedback on CRF design and SDTM datasets for regulatory compliance
Review and provide feedback on SDTM Trial Design Domains
Perform SDTM programming based on specifications
Oversee creation of SDTM datasets, define.xml, annotated CRF, and Clinical Study Data Reviewer’s Guides
Consult on conformance issues for SDTM and ADaM and resolve problems
Represent AbbVie in industry standards development projects
Stay current with industry standards such as CDISC

Qualification

MS with 8 years of relevant experienceBS with 10 years of relevant experienceExperience with ADaM

Required

MS with 8 years of relevant experience, OR
BS with 10 years of relevant experience
Experience with SDTM programming is required
Experience leading development of standards for data collection, tabulation, analysis and/or reporting
Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions

Preferred

Experience with CDASH is highly recommended
Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful
Active participation in CDISC teams preferred
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

Benefits

Dental
Vision
401(k)
PTO

Company

AbbVie

View company page

10000+ employees

Pharmaceuticals

Founded 2013

Source: smartrecruiters

Active within the past hour

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Must-Have Skills for This Role

CDISCSDTMADaMCRF designdefine.xmlFDA submissions

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Manager, Clinical Data & Reporting Standards - SDTM Programming (Hybrid) at AbbVie · LumiJobs