Director, Safety Statistics Group Oncology TA Head

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 Safety Statistics Group (SSG) at AbbVie is an important strategic part of Data and Statistical Sciences (DSS).  Safety Statisticians are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (e.g, product safety team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing.  Safety Statisticians work on products in the AbbVie portfolio ranging from early to later stages of development and life cycle management, with a focus on evaluation, interpretation, and reporting of aggregate/integrated safety data, including benefit risk planning and assessment.

AbbVie is seeking an experienced statistician to serve a Safety Statistics Group Oncology TA Head in our Safety Statistics team. The Director will have oversight of statisticians in oncology.  

This role will be based out of the North Chicago, IL or South San Francisco, CA AbbVie offices - 3 days in office.

Key Responsibilities:

• Provide strategic input to and oversight of the development of Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs).
• Ensure consistency across documents (eg, PSSAP, study SAPs, ISS SAP).
• Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory agencies.
• Attend regulatory meetings.
• Oversight of the development of safety data integration specifications in accordance with analysis plan.
• Lead and provide oversight of contributions by Safety Statistics to benefit-risk planning and assessment, including ens