Senior Manager, Safety Statistics Group

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

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 join our growing Safety Statistics team. The Senior Manager in the Safety Statistics Group will be a member of one or more Product Safety Teams (PSTs).

Key Responsibilities:

• Primary author 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).
• Lead the development of safety data integration specifications in accordance with analysis plan.
• Collaborate with cross-functional team on benefit-risk planning and assessment, including leading the assessment and development of quantitative benefit-risk methods and data displays and ensuring delivery and interpretation of these displays/analyses.
• Lead the development, delivery and interpretation of safety outputs, including graphics.
  • Lead the cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests.
  • Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to agreed-upon timelines.
  • Ensure appropriate interpretation of safety deliverables in collaboration with other functions.
• Lead within-SSG efforts and represent SSG in cross-functional efforts to identify and implement strategic initiatives that address processes related to interpreting, monitoring, assessing, and reporting safety data to better characterize the safety profile of AbbVie products, improve efficiencies, and provide greater consistency across therapeutic areas.
• Stay current with industry trends and practices related to safety.
• Mentor team members.

Qualifications

Qualifications:

• MS (with at least 8 years of relevant experience) or PhD (with at least 4 years of relevant experience) in Statistics, Biostatistics, or a highly related field
• Pharmaceutical or related industry experience including experience and understanding of drug development in the regulated environment
• Effective oral and written English communication skills
• High degree of competence in experimental design, descriptive and inferential statistics, and statistical programming
• Experience interacting with regulatory agencies or with supporting regulatory responses is desirable
• Some experience supporting safety-related projects (eg, ISS, benefit-risk assessment, signal detection) is preferred

Key Leadership Competencies:

• Builds strong relationships with peers and cross functionality with partners outside of team to enable higher performance
• Learns fast, grasps the 'essence' and can change the course quickly where indicated
• Raises the bar and is never satisfied with the status quo
• Creates a learning environment, open to suggestions and experimentation for improvement
• Embraces the ideas of others, nurtures and manages innovation to reality

Significant Work Activities
N/A
Travel
Yes, 15 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.