Senior Analyst, Clinical Data Systems

AbbVie Inc.; Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

AbbVie Data Science is a leading team responsible for delivering clinical trial value by integrating people, processes, and technology. The role drives system design, data flow, and end-to-end delivery against program objectives.

The position requires helping ensure compliance with GCP/ICH and AbbVie SOPs while mentoring junior staff and collaborating across cross-functional teams to optimize data and study outcomes.

Qualifications

• 3+ years of clinical technology experience or 5+ years in a similar technical/clinical role.
• Knowledge of CDASH and SDTM.
• Strong communication and analytical skills.

Responsibilities

• Translate study protocols into system designs and enforce data standards.
• Design and deliver clinical systems and ensure data flow is optimized.
• Coordinate system integrations (e.g., EDC, IRT) and manage changes.
• Track study progress using project management tools and plan work.
• Identify risks to timelines/quality and develop mitigation options.
• Ensure TA- and program-level consistency across deliverables.
• Collaborate with DSS and cross-functional teams to meet objectives.
• Adhere to GCP, ICH guidelines, AbbVie SOPs and regulatory requirements.
• Coach and mentor Data Science Associates and participate in process improvements.

Skills

Clinical technology

Data standards

Communication

Analytical skills

Influence without authority

Education

Bachelor's degree; Masters preferred

Tools

EDC

IRT

ePRO

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

AbbVie 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.

Responsibilities

• Ensures that the requirements of each study protocol are reflected in systems designs and that common data standards are used
• Ensures that systems are specified to optimize on functionality, end user experience, and data flow
• Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to clinical systems (e.g., EDC, IRT,).
• 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
• Ensures that TA- and program-level consistency is achieved
• 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, 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
• Responsible for coaching and mentoring Data Science Associates
• Participates in DSS and cross-functional innovation and process improvement initiatives

Qualifications

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred
• Must have 3+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 5+ years of experience in a similar technical role or in a clinical development role.Experience with common industry design and development tools preferred
• Demonstrated understanding of clinical trial process
• Knowledge of CDASH and SDTM
• Demonstrated ability to influence of others without direct authority
• Demonstrated effective communication skills
• Demonstrated effective analytical skills

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html