Systems Design Analyst II

Abb Vie Data Science is the best‑in‑class team within its cross‑industry peer group and is 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 key to ensuring successful delivery against the program‑ and study‑level accountabilities assigned to Data and Statistical Sciences.

• Actively participates in the development of common data standards and ensures system designs comply with the standards, as well as with associated protocol requirements. Ensures that the design team utilizes standards.
• Establishes and maintains methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards. Ensures that systems are specified to optimize functionality, end‑user experience, and data flow. Ensures the design team meets these expectations.
• Ensures that TA‑ and program‑level consistency is achieved by the design team.
• Accountable for the on‑time design and delivery of new clinical systems, integrations between systems, and any required changes to clinical systems (e.g., EDC, IRT, ePRO). Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
• Interacts with and influences DSS and cross‑functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies.
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Abb Vie Standard Operating Procedures (SOPs), and functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development.
• Responsible for coaching and mentoring members of the team, and contributes to their skill development.
• Leads DSS and cross‑functional innovation and process improvement initiatives.

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred.
• Must have 5+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 7+ years in a similar technical role or in a clinical development role. Experience with common industry design and development tools required.
• In-depth knowledge of clinical trial process, CDASH and SDTM.
• Demonstrated performance as a key contributor to initiatives and advancement of the organization.
• Demonstrated ability to influence others without direct authority, to coach/mentor in a matrixed environment, and to communicate analytically.

• 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 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.

Abb Vie 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.