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
- 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