Director, Clinical Data and Reporting Standards

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

The Director of Clinical Standards is a leadership role which sets the strategy for development and governance of clinical data and reporting standards.  This role carries significant autonomy in envisioning and deploying modern technology and AI powered standards development and is directly responsible for ensuring that AbbVie’s clinical data collection conforms to CDISC standards and all applicable regulatory requirements ensuring submission ready SDTM data .  He/She is responsible for fostering standards-based culture through stakeholder collaborations, establishing training programs and promoting adoption of best practices. 

Responsibilities

• Industry Standards  - Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic submission of data.  Keeps abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management and data warehousing.
• eCRF Design  -  Demonstrates extensive understanding of CDASH and SDTM standards and concepts.  Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards.  Recognizes limitations of eCRF design and suggests solutions proactively.
• SDTM Conformance Mapping  -  Demonstrates extensive understanding of SDTM, Standard Terminology and common coding dictionaries.  Able to critically review SDTM conformance mapping specifications.
• CDISC Validation Tools  -  Demonstrates extensive knowledge of SDTM, ADaM and define.xml validation rules and able to appropriately interpret results from common validation tools.
• Technology   - Responsible for configurat