Associate Director/Assistant Director, Safety Statistics
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 in a leadership role in our growing Safety Statistics team. The Associate 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. -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.•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.•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.•Stay current with industry trends and practices related to safety.•Potentially represent SSG/DSS on external initiatives to advance the safety discipline (eg, 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.
For Associate Director:
- M.S./Ph.D. in Statistics, Biostatistics or a related field.
- At least 6-10 yrs (PhD) or 12 -14 yrs (MS) experience in pharmaceutical development and applied statistics/statistical consulting with a minimum of 2 years of mentorship and/or management experience.
- Advanced knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development.
- Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience. Experience in leading NDA, BLA, and or CTD submission preferred. Experience interacting with regulatory agencies highly desirable.
- Excellent communication skills, both oral and written.
- M.S./Ph.D. in Statistics, Biostatistics or a related field
- At least 6-8 yrs (PhD) or 10-12 yrs (MS) experience in pharmaceutical development and applied statistics/statistical consulting
- Project lead experience required
- Broad knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development
- Experience interacting with regulatory agencies highly desirable
- Excellent communication skills, both oral and written
- Jointly with other project team members, develops and evaluates options for meeting project team goals under time and resource constraints
- Proposes and evaluates options for responding to questions from internal and external sources, including regulatory agencies
- Implements the agreed upon solution after discussion with other stakeholders.Identifies opportunities for, and leads teams for process improvement initiatives
- Actively participates in risk assessment and development of contingency plans
- Productive in relevant statistical research and problem solving
Equal Opportunity Employer Minorities/Women/Veterans/Disabled