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 Director, Safety Statistics will have oversight of statisticians in one or more therapeutic areas.
- 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 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.
- 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.
- 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).
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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.
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 law.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.