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 (https://www.tiktok.com/@abbvie) .
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 configuration of the Metadata Repository and maintaining optimum business process for managing libraries of CDISC related metadata, terminology and related standards.
Programming Standards - Has technical acumen to effectively collaborate with Statistical Programmers in co-leading development of programming standards maintained within the Statistical Computing Environment.
Policies and Procedures - Develop, implement and execute data standards policies, procedures, and practices.
Communication - Effectively and persuasively presents data standards concepts, assessment of risks and logical arguments to R&D functions, especially statistical programmers, statisticians, data scientists, data managers, medical directors, and regulatory function.
Training and Mentoring - Provides strong professional and technical leadership to maintain highly motivated staff. Arranges appropriate training opportunities for staff to facilitate their timely career development. Ensures consistency of training opportunities across the organization. Ensures that self and staff are compliant with training requirements.
Resource Management - Manages data standards staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with suitable quality. Allocates resources to projects such that the correct balance of expertise and experience is maintained for all projects.
Performance Management - Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals. Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honest communication where all are encouraged to express their views.
Qualifications
MS with 12+ or BS with 14+ years of relevant clinical development experience.
Expert level of knowledge of clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define and controlled terminology.
Experience in mapping and converting legacy data into SDTM domains for eCTD submissions. Minimum of two successful submissions of CDISC compliant data.
Experience in developing/instituting standard procedures, guidelines and templates.
Knowledge of international regulations, requirements and guidance associated with clinical data standards and the preparation of data sets for regulatory submission.
Technical skills and experience in directly managing and/or collaborating with the programming group on end-to-end standardization and automation
Experience with metadata repository technology and its application in clinical data standards
*This position will be required to sit on-site 3 days / week in Irvine
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?
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. This range may be modified in the future. ?
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 short-term incentive programs. ?
This job is eligible to participate in our long-term incentive programs?
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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. ?
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.
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