Director, Statistics

1 month ago

North Chicago, United States AbbVie Full time

**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 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.
- 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 safety-related projects (e.g., ISS, PSSAP, 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

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

  • Director, Statistics

    1 month ago

    North Chicago, United States AbbVie Full time

    **Company Description** Purpose The Director, Statistics provides scientific and statitical leadership for assigned clinical development projects. A visible and collaborative role, the Diector works in partnership with clinical and regulatory experts to advance medicines to our patients. **Responsibilities**: - Lead the statistical support for one or...

  • Director, Statistics

    4 days ago

    North Chicago, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Director, Statistics

    5 days ago

    North Chicago, United States AbbVie Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie'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...

  • Director, Statistics

    4 days ago

    North Chicago, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Associate Director, Safety Statistics

    4 days ago

    North Chicago, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Director, Statistics

    5 days ago

    Chicago, Illinois, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Director, Statistics

    4 days ago

    Chicago, Illinois, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Director, Statistics

    5 days ago

    Chicago, Illinois, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Associate Director, Safety Statistics

    4 days ago

    Chicago, Illinois, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Executive Medical Director, Hematology

    4 days ago

    North Chicago, United States AbbVie, Inc Full time

    Company Description 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...

  • Administrative Support Assistant

    2 weeks ago

    North Chicago, United States U.S. Military Entrance Processing Command Full time

    Participate in the development of Directorate clerical/administrative policy in administrative support areas by researching prior publications, regulations, and recommending new policies and/or changes. Formulate and recommend changes in administrative support policies/procedures to obtain maximum...

  • Executive Medical Director, Hematology

    5 days ago

    North Chicago, United States AbbVie Full time

    Company Description 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...

  • Executive Medical Director, Oncology, Solid Tumors

    5 days ago

    North Chicago, United States AbbVie, Inc Full time

    Company Description 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...

  • Senior Director, Financial

    5 days ago

    Chicago, Illinois, United States YMCA Full time

    The Senior Director, Financial & Operational Analytics provides critical analysis of YMCA's financial and operational data.Job DescriptionThe Senior Director, Financial & Operational Analytics provides critical analysis of YMCA's financial and operational data while developing resources which will be utilized by the Y-USA and the Movement. This position will...

  • Director - Risk and Performance Improvement

    4 weeks ago

    Chicago, United States Garfield Park Behavioral Hospital Full time

    **Responsibilities**: W are looking for a knowledgeable and savvy Director of Risk Management and Performance Improvement to serve as a key member of the hospital leadership team. **JOB SUMMARY**:The Director of Performance Improvement organizes, plans, develops, implements and oversees all performance improvement activities of the Hospital. Coordinates,...

  • Executive Medical Director, Oncology, Solid Tumors

    4 days ago

    North Chicago, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Director of Institutional Research

    3 weeks ago

    Chicago, United States InsideHigherEd Full time

    Job Title:Director of Institutional ResearchReports To and Evaluated by:Vice President of Academic AffairsRequired Qualifications:Master’s degree in statistics, mathematics or a research-based discipline. In depth understanding of research design, statistics, and strategic planning. Demonstrated proficiency in creating complex relational databases and...

  • Executive Medical Director, Oncology, Solid Tumors

    5 days ago

    North Chicago, United States AbbVie Full time

    Company Description 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...

  • Executive Medical Director, Oncology, Solid Tumors

    3 days ago

    North Chicago, United States AbbVie Full time

    Company Description 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...

  • Associate Director, Data Science

    5 days ago

    Chicago, United States Ph.D. LLC Full time

    Title: Associate Director, Data Science Agency: PHD at OmnicomMediaGroup Location: CHI 225 N Michigan Ave, 3x a week in office At PHD, we provide our clients with powerful and innovative media strategies, along with big ideas that are driven by insights. PHD Data Scientists deliver analytic solutions across a wide variety of client applications and help...