System Design Analyst I, Clinical Data Systems

AbbVie; California (MO); On-site; USD 110,000 - 165,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Data Science professional to drive design and delivery of clinical data systems, ensuring data standards and end-to-end data flow across studies. You will influence cross-functional teams to meet program objectives and stay aligned with regulatory requirements.

The role emphasizes mentoring junior associates, driving process improvements, and collaborating with DSS to optimize study delivery and data quality. Strong communication and analytical skills are essential.

Qualifications

• Bachelor’s degree in business, MIS, computer science, life sciences or equivalent.
• Masters preferred
• 3+ years of clinical technology experience (EDC, IRT, ePRO) or 5+ years in a similar technical/clinical development role.
• Knowledge of CDASH and SDTM.
• Strong communication and analytical skills.

Responsibilities

• Ensure study protocols are reflected in systems designs and that data standards are used.
• Design systems for functionality, end user experience, and data flow.
• Own on-time design and delivery of new clinical systems and integrations; manage timelines and risk.
• Coach and mentor Data Science Associates.
• Collaborate across DSS and cross-functional teams to meet program objectives.
• Ensure compliance with GCPs, ICH guidelines, AbbVie SOPs and local regulations.

Skills

Influence without authority

Communication

Analytical skills

Mentoring/leadership

Education

Bachelor’s degree in business or life sciences or related field

Masters preferred

Tools

EDC

IRT

ePRO

CDASH/SDTM

Job description

About AbbVie

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.

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

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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

• 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

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

• 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 this 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 short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable 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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html