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Director, Statistics

Employer
AbbVie
Location
Lake County, Illinois
Start date
May 24, 2023

Job Details

The Director, Statistics provides scientific and statistical leadership for assigned clinical development projects. A highly empowered, visible and collaborative role, the Director works in partnership with clinical and regulatory experts to advance medicines to our patients.

Responsibilities:

  • Lead the statistical support for one or more clinical development projects through own efforts or those of a team. Lead statistical strategy for project development and regulatory submission.
  • Direct and review the development of design, analysis and reporting for clinical or other scientific research programs. Review protocols, statistical analysis plans, and statistical programing plans.
  •  Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects. Represent DSS on data monitoring committees. Build interdepartmental relationships.
  • Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
  • Lead strategy and direct development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming and other stakeholders.
  • Train and mentor staff on statistical methodology and operations. May supervise a group of statisticians as a people manager. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
  • Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
  • Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities. Build external scientific connections which foster professional development and promote the reputation of the Statistics department
  • Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Represent DSS in discussions with regulatory agencies and on Advisory Committees.
  • Develop an external presence within the statistics community and represent AbbVie on advanced and emerging topics.

  • MS (with 14+ years of experience) or PhD (with 10+ years of experience) in Statistics, Biostatistics, or a highly related field.
  • High degree of technical competence and excellent communication skills, both oral and written
  • Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from other
  • Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo
  • Have strong leadership skills and experience in working/managing cross-cultural or oversea teams
  • Pharmaceutical industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.
  • Prior experience in Immunology is preferred
  • For people mangers, prior experience of people management is required

 

Key Stakeholders

·            Clinical development experts

·            Statistical programmers

·            Data science experts

·            Global Medical Affairs experts

·            Regulatory experts

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.


Company

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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