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About AbbVie

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, YouTube and LinkedIn.

Director, Statistics

Irvine, California Req ID 2207933 Category Research and Development Division AbbVie

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

 Major Job Responsibilities

  • Provide statistical expertise and support for one or more clinical development projects through own efforts or those of a team; lead/develop statistical strategy for project development and regulatory submissions
  • Plan, direct and organize all statistical activities for the assigned projects including study protocol development, statistical methods, data analysis and interpretations; make sure clinical trials are optimally designed, properly analyzed and clearly presented to support new product development, regulatory submissions and the maintenance and growth of existing products
  • 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; may represent DSS on Data Monitoring Committees; build interdepartmental relationships
  • Demonstrate in-depth understanding of statistical concepts and broad knowledge in methodologies; propose novel statistical methodological approaches to design of scientific studies; gain expertise in innovative statistical methods
  • Provide sufficient detail to allow programming implementation; ensure that all statistical analyses specified in study protocols and analysis plans are scientifically sound and executed appropriately.
  • Guide development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming, and other stakeholders
  • Manage resources and timeline to ensure that statistical deliverables are generated with high quality and completed by the agreed timeline; ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures following department standards
  • Train and mentor staff on statistical methodology and operations
  • Develop strategy for data presentation and inference; ensure appropriate interpretation of statistical deliverables in collaboration with other functions; collaborate with team for publications of scientific research
  • 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 work processes follow all applicable regulatory requirements; conduct critical review of regulatory submission documents; may represent DSS in discussions with regulatory agencies.
Qualifications:
  • Qualifications

    • MS (with 12+ years of experience) or PhD (with 8+ 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 others

    • 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 teams

    • Pharmaceutical or related industry knowledge required, including direct experience and good understanding of drug development and life-cycle management in a regulated environment.

    Key Stakeholders

    • Clinical development experts

    • Regulatory experts

    • Statistical programmers

    • Data science experts


    Significant Work Activities
    Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
    Travel
    Yes, 5 % of the Time
    Job Type
    Experienced
    Schedule
    Full-time
    Job Level Code
    D
    Equal Employment Opportunity
    At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.

     

     

    MS (with a minimum of 12 years of experience) or PhD (with a minimum of 8 years of experience) in Statistics, Biostatistics, or a highly related field.
  • Excellent English communication skills, both oral and written.
  • Advanced knowledge of statistical methodology including experimental design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience.
  • At least 12 years (MS) or 8 years (PhD) of experience in pharmaceutical development. Experience in leading NDA, BLA, and or CTD submission preferred (for clinical statistics only). Understanding of and global regulatory requirements. Experience interacting with regulatory agencies highly desirable.
  • Management experience required for people managers.
Significant Work Activities: N/A
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
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