Associate Director, Safety Statistics (Hybrid)

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

**This is a hybrid position. Must be local to Lake County, IL and work on-site 3 days a week. 

The Associate Director, Safety Statistics provides scientific and strategic input and safety statistics leadership for assigned clinical development projects. A visible and collaborative role, the Associate Director works in partnership with patient safety, clinical, and regulatory experts to advance medicines to our patients.

 Responsibilities:

• Lead the Product Safety Team (PST) statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop safety statistical strategy for project development and regulatory submission.
• Direct or provide safety statistical leadership in the safety analysis and reporting for clinical data and ensure appropriate interpretation of safety deliverables in collaboration with other functions. 
• Author and provide strategic input to the development of Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs) and development of safety data integration specifications in accordance with analysis plan.
• Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory agencies. 
• Lead cross-functional development, delivery, and interpretation of safety outputs, including graphics. Lead cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests. Ensure the delivery of high-quality outputs according to agreed-upon timelines.
• Represent function/department on project team(s) to provide statistical inpu