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

AbbVie; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Comprehensive benefits

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to drive the development and governance of data and reporting standards across Abbvie's clinical trial portfolio. The role emphasizes SDTM/ADaM design, SDTM programming, and documentation for regulatory submissions.

The candidate will lead cross-functional teams to define data collection, review rules, and trial-level reporting displays, while ensuring consistency with eCRF and CDISC standards.

Qualifications

• Experience with SDTM required and demonstrated history of standard development.
• Ability to lead data collection, tabulation, analysis, and reporting standards.
• Experience preparing SDTM/ADaM datasets for regulatory submissions.
• CDISC/CDASH familiarity is preferred.

Responsibilities

• Develop data and reporting standards in support of AbbVie's clinical trials.
• Govern SDTM/ADaM frameworks and ensure alignment with industry best practices.
• Create training materials on standards use for pipeline teams.
• Communicate ongoing standard development activities across the organization.
• Oversee SDTM datasets, define.xml, annotated CRFs for submissions.

Skills

SDTM experience

ADaM mapping

Data collection standards

Regulatory submissions

CDASH familiarity

Education

MS with 8+ years clinical research experience

BS with 10+ years clinical research experience

Job description

Job Description

The Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials and ensuring AbbVie’s conformance to CDISC standards and industry best practices as well as pipeline‑based SDTM development. This role implements the strategy and framework for governance of standards as set by the Head and Associate Directors of CDARS and actively engages in deployment of next generation process and technology.

Responsibilities

Standards Development Responsibilities

• Actively participating with a cross‑functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
  • Data Collection
  • Data Review Rules
  • SDTM mapping
• Participating in a cross‑functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
  • ADaM mapping and derivation
  • Study‑level tables, listings, or figures
  • Product‑level safety analysis displays
• Ensuring each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities.
• Ensuring consistency across standard types (e.g., eCRF standards align with TLF standards, SDTM standards align with ADaM standards, etc.).
• Develop training materials to the organization on the proper use of standards in pipeline activities.
• Communicate ongoing standard development activities across the organization.

Pipeline Responsibilities

• Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that supports regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC.
• Review and provide feedback on SDTM Trial Design Domains.
• SDTM programming based on SDTM specifications.
• Oversee the creation of SDTM datasets, define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions.
• Consult on conformance issues for SDTM and/or ADaM and work with the study team to resolve the problem either by correcting the data or metadata, or by providing an appropriate explanation.

Other Responsibilities

• Representing AbbVie’s interests in industry standards development projects.
• Staying current with industry standards such as CDISC, and the regulatory requirements related to their use.
• Identifying improvements to the processes and content of standards, and driving those improvements to completion.

Qualifications

Minimum Qualifications

• MS with 8 years of relevant clinical research experience, or
• BS with 10 years of relevant clinical research experience.
• Experience with SDTM 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

• Experience with CDASH is highly recommended.
• Experience with ADaM, Analysis Results Metadata, or TLF standards is helpful.
• Active participation in CDISC teams is preferred.

Compensation & Benefits

• 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.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long‑term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico applicants seeking a reasonable accommodation can learn more at https://www.abbvie.com/join-us/reasonable-accommodations.html.