Senior Data Standards Analyst Remote (CDISC/CDASH/SDTM)

Abbvie; Honolulu (HI); Remote; USD 110,000 - 160,000; Full time

Job summary

AbbVie is seeking a Senior Data Standards Analyst to contribute to data and reporting standards for clinical trials, focusing on CDASH and SDTM within immunology and related areas. You will work with cross-functional teams to define SDTM/ADaM mappings, write clear documentation, and ensure alignment with regulatory submission requirements.

The role emphasizes education and communication of standards across the organization.

Qualifications

• Expert level knowledge in CDASH/SDTM/ADaM/define.xml and terminology.
• Experience mapping and converting legacy data into SDTM domains for submissions.
• Familiarity with BRIDG, ODM, SHARE standards.

Responsibilities

• Develop SDTM mapping specifications and trial design domains.
• Provide feedback on CRF design and SDTM data sets for regulatory compliance.
• Oversee define.xml, annotated CRFs and study data reviewer guides for submissions.
• Advise on conformance issues and resolve data/metadata problems.

Skills

CDISC standards

SDTM mapping

ADaM mapping

CRF design feedback

define.xml

regulatory submission

Education

MS with 6 years clinical research

BS with 8 years clinical research

Tools

metadata repository

Job description

AbbVie is seeking a Senior Data Standards Analyst to contribute to data and reporting standards for clinical trials, focusing on CDASH and SDTM within immunology and related areas. You will work with cross-functional teams to define SDTM/ADaM mappings, write clear documentation, and ensure alignment with regulatory submission requirements.

The role emphasizes education and communication of standards across the organization.