Analyst II, Clinical Technology (IRT)

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Purpose:

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.

Responsibilities:

• Supports development of data and statistical technology strategy by supplying knowledge and information related to supported domain. Assesses new domain-specific technologies in collaboration with IT and technology partners. Works with IT, functional partners, vendors and TQM to assist in the alignment of domain-specific DS technology and process to optimize against the defined strategy
• Utilizes defined standards and domain-specific knowledge to optimize clinical data flow from collection to analysis-ready datasets.
• Utilizes available technology and designed mappings from source data structures to fit-for-purpose data models (e.g., SDTM, data review). Ensures traceability of data through the systems pathway
• If assigned, and based on supported domain(s): -Defines and develops electronic data capture systems for the collection of clinical trials data -Builds specifications for data acquisition from third-party systems
• Defines and develops systems integrations -Builds specifications for interactive response technology (IRT)
• Acts as DS technology point of contact and works closely with data and statistical colleagues, and cross functional stakeholders to troubleshoot data flow interruptions and potential errors
• Maintains technical knowledge of and supports multiple data systems using knowledge of how the capability contributes to the submission data flow and overall DSS technology strategy
• Responsible for coaching and mentoring junior team members. May include indirect supervision of contract resources
• Collaborates with global functional and cross-functional teams including IT and technology specialists from peer organizations. Ensures that DSS tech strategy aligns with supported domain. Also aligns with business process owners
• Participates in oversight of technology vendors and provides feedback related to clinical trial operations, issues and trends in performance Participates in functional and cross-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

Qualifications

• Bachelor's degree in business, management information systems, computer science, life sciences, engineering or equivalent. Master's preferred.
• 6+ years of pharmaceutical, clinical research, data management, health care technology experience or 8+ years of broader technology experience.
• Demonstrated intermediate SAS and/or SQL programming skills and intermediate knowledge of database concepts.
• Deep understanding of IRT tools (Endpoint, Cenduit, and Trident)
• Demonstrated knowledge of CDASH and SDTM Standards.
• Demonstrated leadership traits and ability to influence without authority.
• Demonstrated performance as a key contributor to initiatives and advancement of the organization.
• Demonstrated ability to successfully coach/mentor in a matrix environment.
• Demonstrated effective communication skills.
• Demonstrated effective problem-solving and analytical skills.

Significant Work Activities
N/A
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.