at AbbVie US LLC in North Chicago, Illinois, United States
Job Description
Data Science Program Lead II, AbbVie Inc., North Chicago, IL. Align Data & Statistical Science (DSS) study teams with program & study-level strategies. Lead the DSS Study Team & represent DSS as a member of cross-functional study team. Act as single point of contact & accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives. Utilize clinical trial systems including Electronic Data Capture (EDC), Interactive Response Technology (IRT) & Clinical Trial Management Systems (CTMS). Utilize understanding of Laboratory data, Clinical Outcomes Assessments (COA/eCOA), ECG, IRT, Pharmocokinetic & other external data types. Engage & connect global functional & cross-functional teams at study level. Interact with & influence cross-functional team members to achieve program objectives. Plan, coordinate, & deliver data management tasks within timeline. Utilize operational analytics & project management tools to optimize execution of programs & studies, manage internal & external resources, track study progress, & prepare study status reports. Author, revise, & review data management related plans & documentation, including Data Management Plan, Data Review Plan, Electronic Case Report Form (eCRF), & completion Guidelines. Anticipate & identify issues that could affect timelines or quality & develop options & solutions, identify & mitigate risk and contribute to Risk Assessment & Management Plan. Ensure adherence to federal regulations & applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), & functional quality standards. Perform project management skills including metrics analysis & reporting methodologies. Keep abreast of new &/or evolving local regulations, guidelines & policies related to clinical development. Participate as DSS study owner in regulatory inspections & internal quality audits. Participate in oversight of vendors & provide feedback related to clinical trial operations, issues, & trends in performance. Utilize reporting & data visualization tools such as Spotfire, J-Review, Business Objects &/or SAS to generate data review listings, also, project management tools such as Microsoft Project, Smartsheet or equivalent. Responsible for coaching & mentoring team members. Lead DSS innovation & process improvement initiatives & participates in cross-functional initiatives. Conduct study execution across functions. Conduct indirect supervision of employees as well as supervision of work of contract resources. Must possess a Bachelor’s degree or foreign academic equivalent in Biology, Biotechnology, Information Technology, Business, or a related field of study with at least 2 years of experience in the following: (i) Electronic Data Capture (EDC), Interactive Response Technology (IRT) & Clinical Trial Management System (CTMS); (ii) planning, coordinating, & delivering data management tasks within timeline; (iii) authoring, revising, & reviewing data management related plans & documentation, including Data Management Plan, Data Review Plan, Electronic Case Report Form (eCRF), and Completion Guidelines; (iv) project management skills including metrics analysis & reporting methodologies; & (v) Spotfire, J-Review, Business Objects &/or SAS to generate data review listings. Position requires work at various & unanticipated work locations throughout the U.S. 100% telecommuting permissible. Apply online at https://careers.abbvie.com/en & reference REF23193M
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