Associate Director - Data Standards (Hybrid)

Responsibilities

• Lead, manage and develop a group of data standards experts to develop, implement and maintain end-to-end data standards from data collection to regulatory submission.
• Govern change control, publication and communication of new and updated data standards.

Qualifications

• Minimum Qualifications: Bachelors of Science
• 12+ years of relevant clinical research experience (or 10+ years with a Masters)
• Expert level of knowledge of at least 3 areas of clinical data standards, and high level of knowledge in at least one additional area.
• Familiarity with other clinical data standards including BRIDG, ODM and SHARE
• Experience in mapping and converting legacy data into SDTM domains for eCTD submissions
• Minimum of two successful submissions of CDISC compliant data
• Knowledge of international regulations, requirements and guidance associated with clinical data standards and the preparation of data sets for regulatory submission
• Experience with metadata repository technology and its application in clinical data standards processes and experience with data standards governance
• Experience in management of metadata to support efficient use of systems and processes

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 long-term incentive programs.

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 employer 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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