AbbVie

Manager, Clinical Data & Reporting Standards

Employer
AbbVie
Location
Lake County, Illinois
Posted
Nov 29, 2021
Ref
2113174
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Clinical Data and Reporting Standards

Multiple locations – Lake County IL (preferred), Sunnyvale CA, Madison NJ or Remote US

The Manager, Clinical Data and Reporting Standards (CDARS) works in a cross-functional setting to develop and maintain a library of standards,  proactively promotes standards driven culture among clinical study teams to streamline portfolio pipeline activities. He/she continuously scans the regulatory landscape to ensure AbbVie’s conformance to CDISC standards and industry best practices. 

 

Opportunity to be involved in developing and maintaining a library of standards that are used by study teams to streamline pipeline activities in the Data & Statistical Sciences department.  Secondary responsibilities include supporting pipeline work across multiple therapeutic areas and indications by providing subject matter expertise on CDISC conformance and AbbVie standards.

Standards Development responsibilities may include

  • Participating in a cross-functional team of subject matter experts to define one more of the following types of standards within a therapeutic area or across therapeutic areas:
    • Data Collection
    • Data Review Rules
    • SDTM mapping
    • 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. ADaM standards align with TLF standards, SDTM standards align with ADaM standards, etc.)
  • Train the organization on standards and advise on use of standards in pipeline activities
  • Communicate ongoing standard development activities across the organization

Pipeline responsibilities may include

  • Review and provide feedback on CRF design, SDTM datasets, and/or ADaM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC
  • Define SDTM mapping, including Trial Design Domains
  • Create SDTM 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 include:

  • 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

Qualifications

  • Experience developing standards for data collection, tabulation, analysis and/or reporting
  • Experience with ADaM, Analysis Results Metadata, and TLF standards preferred
  • Knowledge of CDSIC standards (CDASH, SDTM and/or ADaM ) and their application in regulatory submissions is a must
  • Active participation in CDISC teams preferred
  • Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
  • Experience with standards related to immunology or medical devices preferred
  • Experience with standards related to oncology, eye care, neuroscience, virology, women’s health or medical aesthetics helpful

Education and experience requirements

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

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.