Clinical Data Systems Design Analyst II

AbbVie; Florham Park (NJ); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) retirement plan

Short-term incentive programs

Job summary

AbbVie Data Science leads the delivery of data strategy for clinical trials, focusing on design standards, data flow, and system integrations. The team coordinates across regulatory, data management, and IT to ensure compliant, scalable solutions.

The role requires deep knowledge of CDASH/SDTM, 5+ years in EDC, and the ability to mentor teams while driving process improvements in a fast-paced, regulated environment.

Qualifications

• Bachelor’s degree in business, MIS, computer science, life sciences or equivalent
• Masters preferred
• 5+ years of hands-on technical Study build in EDC
• Experience with Medidata RAVE is required
• Veeva EDC technical study build experience is a plus
• In-depth knowledge of clinical trial processes
• CDASH and SDTM knowledge
• Ability to influence without direct authority
• Strong communication and analytical skills

Responsibilities

• Actively participates in developing common data standards and ensures designs comply with standards and protocol requirements
• Establishes and maintains methodology to design and develop clinical trial systems, benchmarking against industry standards
• Ensures TA- and program-level consistency in design team outputs
• Accountable for on-time design and delivery of new clinical systems and integrations
• Interacts with CDO and cross-functional team members to align objectives
• Ensures adherence to GCPs, ICH guidelines, AbbVie SOPs, and regulatory standards
• Coaches and mentors team members and leads innovation and process improvement

Job description

AbbVie Data Science leads the delivery of data strategy for clinical trials, focusing on design standards, data flow, and system integrations. The team coordinates across regulatory, data management, and IT to ensure compliant, scalable solutions.

The role requires deep knowledge of CDASH/SDTM, 5+ years in EDC, and the ability to mentor teams while driving process improvements in a fast-paced, regulated environment.