AbbVie is a company dedicated to discovering and delivering innovative medicines and solutions. They are seeking a Clinical Data Systems Analyst to ensure successful delivery of program- and study-level accountabilities assigned to Data and Statistical Sciences, while engaging with cross-functional teams and adhering to regulatory standards.
Uses understanding of clinical trial concepts and cross-functional protocol requirements to execute assigned study assignments
Engages with members of the DSS and cross-functional study teams in order to effectively execute assigned activities
Effectively utilizes available technology to execute assigned activities
Utilizes data standards (e.g., CDASH and SDTM) in the design and development of key system interfaces and end-to-end data flow
Supports the execution of all processes in support of study startup, conduct and close-out
Performs data analyses in support of operational decision support
Supports development of clinical trial application design specifications
May complete rotation through multiple DS roles to establish a base proficiency and to develop a holistic understanding of Data and Statistical Sciences and of clinical development stakeholders
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
Qualification
Required
Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent.
Must have 2+ years of clinical research, analytics, life sciences or comparable experience (or) a master’s degree with no previous experience
Project Management experience
Demonstrated performance as a key contributor to initiatives and advancement of their organization (academic, internships, or in a previous job)
Demonstrated effective communication skills
Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively
Demonstrated problem-solving and analytical skills
Demonstrated leadership traits and ability to influence others without direct authority
Preferred
Master’s degree preferred
eCOA experience
Benefit
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
