Senior Manager, Safety Statistics

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

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

Responsibilities:

• Serve as the Product Safety Team (PST) statistician for one or more clinical development projects. Lead/develop safety statistical strategy for project development and regulatory submission.
• Provide statistical leadership in the safety analysis and reporting for clinical data and ensure appropriate interpretation of safety deliverables in collaboration with other functions. 
• Author the Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs) and lead the development of safety data integration specifications in accordance with analysis plan.
• Contribute to strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory agencies. 
• Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects. Build interdepartmental relationships.
• Lead cross-functional development of output specifications to address pre-planned safety analyses and ad hoc requests. Provide sufficient detail to allow programming implementation and ensure all statistical analyses specified in analysis plans are conducted appropriately.