Director, Statistics

Full Job Description

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 and Epidemiology (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 in a leadership role in our Safety Statistics team. The Director, Safety Statistics will have oversight of statisticians in one or more therapeutic areas. 

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 ensuring delivery and interpretation of benefit-risk data displays/analyses.

Oversight of the development, delivery and interpretation of safety outputs, including graphics.

Oversight of cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests.

Oversight to ensure the delivery of high-quality outputs according to agreed-upon timelines.

Ensure appropriate interpretation of safety deliverables in collaboration with other functions.

Identify potential areas to improve processes or statistical methodologies, initiate steps to evaluate possible improvements and develop a plan to implement changes based on this evaluation.

Lead within-SSG initiatives and represent SSG on cross-functional efforts to implement strategic initiatives that address processes related to monitoring, assessing, interpreting, and reporting safety data.

Potentially represent SSG/DSS on external initiatives to advance the safety discipline (e.g., ASA, PHUSE, DIA, etc.), depending on individual interests.

Responsible for project and resource management within SSG for therapeutic area(s) of responsibility.

Mentor team members and provide appropriate development opportunities.