SDTM Data Standards Manager - Clinical Data Lead

Allergan; Irvine (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Long-term incentive programs

Medical, dental & vision Insurance

401(k) plan

Job summary

AbbVie is seeking a Manager, Clinical Data and Reporting Standards to lead development and governance of SDTM/ADaM standards across therapeutic areas. You will align eCRF, SDTM, and ADaM with regulatory expectations, build training materials, and collaborate with cross-functional teams to drive standardization in pipeline activities.

The role emphasizes SDTM programming expertise, CDASH/CDISC knowledge, and experience enabling regulatory submissions.

Qualifications

• MS or BS with extensive SDTM/ADaM/SDTM programming experience.
• Experience developing data collection, tabulation and analysis standards.
• Familiarity with CDASH and CDISC standards for regulatory submissions.
• Ability to produce clear documentation and training materials.

Responsibilities

• Develop and govern SDTM/ADaM standards across therapeutic areas.
• Create training materials and communicate standards organization-wide.
• Provide SDTM programming input for regulatory submissions and trials.
• Review CRF designs and SDTM datasets to ensure regulatory compliance.
• Oversee conformance issues and provide appropriate explanations.

Skills

SDTM programming

Data standards development

CDASH/CDISC knowledge

ADaM familiarity

Regulatory submissions documentation

Education

MS with 8 years of relevant clinical research experience

BS with 10 years of relevant clinical research experience

Job description

AbbVie is seeking a Manager, Clinical Data and Reporting Standards to lead development and governance of SDTM/ADaM standards across therapeutic areas. You will align eCRF, SDTM, and ADaM with regulatory expectations, build training materials, and collaborate with cross-functional teams to drive standardization in pipeline activities.

The role emphasizes SDTM programming expertise, CDASH/CDISC knowledge, and experience enabling regulatory submissions.