Clinical Data Analyst

Job Description

Introduction:

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.

Candidate:

• Ensures consistency in analysis techniques and delivery against cross-functional data review requirements
• Is accountable for gathering cross-functional input into the development of Integrated Data Review Plan (IDRP)
• Ensures clinical data integrity and quality prior to analysis.
• Supports cross-functional data review teams using statistical methods and state-of-the-art business intelligence tools

• Aligns DSS study teams with program- and study-level analytics strategies. For assigned studies, works with Data Warehouse Analyst, Statistical Programmer, Statistician and Testers to ensure the context, accuracy and timeliness of work products are optimized
• Is a mandatory DSS Study Team participant and represents the analytic and assigned data review requirements for assigned studies. Connects with cross-functional teams to design work product and as an analytics consultant
• Ensures that data presented, and presentation, maintain study integrity. This role is required to support multiple use cases and should ensure that each work product is fit for purpose
• Works with team to ensure analytical work product is consistent from study to study where appropriate and that user experience is optimized and follows the design principles and standards established by the team
• Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• Leverages proven statistical methodologies and those methodologies established as standard by the team
• Responsible for coaching and mentoring Data Science Associates
• Contributes to study execution ‘lessons learned’ across functions
• If assigned, participates in functional innovation and process improvement initiatives
• 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

Basic:

• Bachelor’s degree statistics, bioinformatics, mathematics, data science or equivalent field. Master’s degree preferred
• Must have 3+ years of clinical research or analytics-related experience
• Intermediate-level proficiency in R, SAS or other statistical packages. Intermediate-level knowledge of statistical and data mining techniques
• Good understanding of clinical trial process and clinical technology. Experience in managing a clinical trial from initiation through to completion is preferred
• Demonstrated effective communication skills. Demonstrated ability to communicate analytical and technical concepts in layman’s terms
• Demonstrated problem-solving and analytical skills
• Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively

• Significant Work Activities and Conditions: N/A
• Travel: No
• Job Type: Experienced
• Schedule: Full-time
• Job Level Code: IC