Director, Statistics - North Chicago, United States - AbbVie

AbbVie

Verified Company

North Chicago, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Company 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 benefitrisk planning and assessment, including ensuring delivery and interpretation of benefitrisk data displays/analyses.
Oversight of the development, delivery and interpretation of safety outputs, including graphics.
Oversight of crossfunctional development of output specifications to address both preplanned safety analyses and ad hoc requests.
Oversight to ensure the delivery of highquality outputs according to agreedupon 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 withinSSG initiatives and represent SSG on crossfunctional 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.

Qualifications

MS (with at least 14 years of experience) or PhD (with at least 10 years of experience) in Statistics, Biostatistics, or a highly related field, with at least 7 years (MS) or 5 years (PhD) of experience in pharmaceutical development.
Minimum of 2 years of management experience required for people managers.
Excellent English 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.
Experience interacting with regulatory agencies.
Experience in leading NDA, BLA, and or CTD submission preferred.
Oversight of multiple safetyrelated projects (e.g., ISS, PSSAP, benefitrisk 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 shortterm incentive programs.
This job is eligible to participate in our longterm incentive programs

Note:

No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.

The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable l