Describe the primary goals, objectives or functions or outputs of this position.
AbbVie Data Science is the best-in-class team within its cross-industry peer group. We are responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is a key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
•Develops deep understanding of supported technology domain and achieves skill set required to fully support the system.
•Utilizes defined standards and domain-specific knowledge to support clinical data flow from collection to analysis-ready datasets.
•Based on supported domain: o Defines and develops electronic data capture systems for the collection of clinical trials data. o Builds specifications for data acquisition from third-party systems. o Defines and develops systems integrations. o Builds specifications for interactive response technology and ePRO. o Creates operational analytics to support ad hoc analyses and metrics reporting.
•Acts as general DS technology point of contact and works closely with data and statistical colleagues to troubleshoot data or process flow interruptions, as well as potential errors.
•Maintains technical knowledge of and supports one or more data systems and uses knowledge of how the capability contributes to the submission data flow and overall DSS technology strategy.
•Collaborates with global functional teams including IT and technology specialists from peer organizations. Maintains supported domain as an element of the DSS tech strategy.
•Responsible for mentoring Data Science Associates.
•Participates in functional innovation and process improvement initiatives.
•Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development. Acts as the clinical data systems SME during regulatory inspections and internal quality audits.
List required and preferred qualifications (up to 10). Include education, skills and experience.
•Bachelor’s degree in business, management information systems, computer science, life sciences, engineering or equivalent. Master’s preferred.
•4+ years of pharmaceutical, clinical research, data management, health care technology experience or 6+ years of broader technology experience.
•Familiar with clinical trial process and clinical technology.
•Demonstrated knowledge of SAS and/or SQL programming skills and knowledge of database concepts.
•Familiar with CDASH and SDTM Standards.
•Demonstrated leadership traits and ability to influence without authority.
•Demonstrated effective communication skills.
•Demonstrated effective problem-solving and analytical skills.
Significant Work Activities: N/A
Job Type: Experienced