Associate Director, Clinical Data & Reporting Standards Details

Associate Director, Clinical Data & Reporting Standards

Abbvie - Madison, NJ

Employment 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.

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

Associate Director (Grade 20) – ADaM and TLF Standards

The Associate Director, Clinical Data and Reporting Standards (CDARS) proactively drives forward the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials, continuously scanning the regulatory landscape and ensuring AbbVie’s conformance to CDISC standards and industry best practices. In collaboration with the Head of CDARS, he/she sets the strategy and framework for governance of standards and actively engages in deployment of next generation process and technology. This role will focus on ADaM and TLF standards.

Standards Development responsibilities include

• Leading a cross-functional team of subject matter experts to define one more of the following types of standards across therapeutic areas (e.g. immune-oncology standards):
  • ADaM mapping and derivation
  • Standard 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, ADaM standards align with SDTM standards, etc.)
• Train the organization on standards and advise on use of standards in pipeline activities
• Communicate ongoing standard development activities across the organization

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
• Managing direct reports

Qualifications

Qualifications

• Knowledge of CDSIC standards and their application in regulatory submissions is a must
• Experience leading development of standards for ADaM, Analysis Results Metadata, and/or TLF standards
• Experience with creating Analysis Results Metadata and/or TLFs
• Active participation in CDISC teams preferred
• Experience with preparing ADaM datasets and documentation for regulatory submissions
• Experience with standards related to immunology, oncology, eye care, neuroscience, virology, women’s health, medical aesthetics, or devices

Education and experience requirements

• MS with 10 years of relevant clinical research experience, or
• BS with 12 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.