Director, Safety Statistics Group Oncology TA Head

Job Opportunity At AbbVie

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.

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.

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.
• Stay current with industry trends and practices related to safety.
• Potentially represent SSG/DSS on external initiatives to advance the drug safety analytics 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.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.

Qualifications:

• MS (with at least 14 years of experience) or PhD (with at least 10 years of experience) in Statistics, Biostatistics.
• Minimum of 2 years of management experience required for people managers.
• Excellent communication skills, both oral and written
• Advanced knowledge of statistical methodology including experimental design, descriptive statistics, inferential statistics, and statistical programming.
• Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience.
• In-depth knowledge and understanding in application of standard business procedures (regulatory guidance, global regulations, ethical issues assoc/iated with scientific research trials, SOPs, etc.).
• Experience interacting with regulatory agencies.
• Experience in leading NDA, BLA, and or CTD submission preferred.
• Oversight of multiple safety-related projects (eg, ISS, benefit-risk assessment, signal detection).

Additional Information:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.