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Director, Global Medical Affairs (GMA) Statistics

Employer
AbbVie
Location
Lake County, IL, US
Start date
Feb 16, 2019

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Discipline
Clinical, Medical Affairs
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work
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Job Details

Overview:

Global Medical Affairs (GMA) Statistics is responsible for providing services in the area of biostatistics and mathematics to Global Medical Affairs and other corporate divisions. These services are supplied in the context of a cooperative, product-oriented effort and included supporting all GMA studies, scientific presentations and publications for all therapeutic areas, evidence evaluations and generations based on real world evidence, and Health Technology Assessment.

Key Responsibilities:

  • Leads and directs statistical planning and strategy development for an assigned therapeutic indication area focusing on the GMA related activities in the assigned indication.
  • Through own efforts and those of their staff provides scientific and statistical expertise for GMA study designs and conduct, scientific presentations and publications, evidence evaluations and generations based on real world evidence, and Health Technology Assessment


GMA Study Protocol Development:

  • Directs the development of scientific protocols, ensuring they are scientifically sound and the research hypotheses and corresponding study designs are aligned with the product strategy, and meet scientific and/or applicable regulatory needs.
  • Ensures statistical methodology is appropriate and sound, consistent with the objective(s) of the scientific explorations


Statistical Analyses:

  • Demonstrates outstanding understanding of statistical concepts and methodologies.
  • Takes a leadership role in introducing new/novel statistical methodological approaches into analysis plans which improve the efficiency and sensitivity of study results.
  • Provides sufficient details to allow programming implementation.
  • Ensures that all the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately


Database Explorations:

  • In collaboration with GMA, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders to assess and evaluate existing databases and real world evidence for evidence evaluation and generation to d eliver useful, customer-centric evidence and insights to drive decisions


Scientific Reports and Publications:

  • Ensures that study results and conclusions are scientifically sound, clearly presented, and supported by the statistical analyses provided. Ensure timely and quality statistical deliverables.
  • Represents GMA Statistics on product issues at management and/or product review meetings.
  • Provides in-depth scientific/statistical review for scientific reports and publications.
  • Ensures the accuracy of the statistical component of scientific reports and/or publications with high quality


Product Team Involvement:

  • Partners with GMA, Clinical Research and Clinical Statistics to develop scientifically appropriate strategies for GMA studies, presentations, and publications in assigned therapeutic area(s).
  • Represents GMA Statistics to provide functional area input for life cycle management of products. Leads communications between assigned product team(s) and functional management.
  • Builds/drives inter-department relationships and teamwork


Consultation:
    Partners with multiple stakeholders to develop scientifically appropriate development strategies for one or more major drug discovery or development projects Effectively plans and manages statistical resources to meet assigned project priorities Works with manager and appropriate administrative staff to arrange for and manage alternative resources (i.e., consultants, CROs, interns, temporary staff) to satisfy needs of assigned projects Interacts with relevant stakeholders to ensure that appropriate statistical methods are adequately and consistently applied in all scientific and regulatory documents, presentations, and publications Provides scientific/statistical insight in addressing questions from clients, and proposes novel solutions to technical issues Independently pursues analyses suggested by the data, including the pursuit of statistical knowledge needed to address the scientific issue In collaboration with Statistical Programming or their designee, ensures that all internal and external statistical software used in the performance of analyses defined in SAPs or scientific research plans are efficient, validated, and meet internal SOPs and external regulatory requirements Acts as the liaison for statistical issues on AbbVie collaborative studies with outside universities, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities Builds external scientific contacts which foster professional development and promote the reputation of the department Demonstrates broad understanding of scientific research designs, worldwide regulatory requirements and commercial aspects of drug development Critically reviews regulatory submission documents for one or more major drug discovery or development projects Effectively and persuasively presents statistical concepts, evidence, interpretations, and logical arguments to the project team, management, regulatory agencies, and scientists


Training, Supervising, Mentoring:
    In conjunction with other directors, and/or administrative management, coordinates and supervises statistical support for the assigned indication or development programs Effectively mentors other development stakeholders with regards to statistical methodology and departmental operations Manages personnel by appropriately delegating assignments, reviewing activities and defining and ensuring review of deliverables so that projects are completed on time with high quality Stimulates the scientific development of staff Develops and supervises departmental seminars, short courses, and the publication/presentation of scientific articles Works with other directors and/or administrative management to develop and arrange appropriate training opportunities for staff and facilitate their timely career development Works with other directors and/or administrative management to recruit qualified statisticians to the organization Ensures that staff and self are compliant with training requirements Demonstrates a high degree of responsibility in maintaining DSS / Biometrics standards, GxP compliance, and best operating practices for staff and self


Basic:

  • M.S./Ph.D. in Statistics, Biostatistics or a related field. At least 8 years (PhD) or 12 -14 years (MS) experience in pharmaceutical development and applied statistics/statistical consulting. Project lead experience required. Broad knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development.
  • Advanced knowledge of statistical methodology and global regulatory requirements, expertise in drug discovery or development, and an understanding of commercial aspects of drug development
  • Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience
  • Experience interacting with external experts and/or regulatory agencies highly desirable
  • Excellent communication skills, both oral and written
  • Jointly with other project team members, develops and evaluates options for meeting project team goals under time and budgetary constraints
  • Proposes and evaluates options for responding to questions from internal and external sources, including regulatory agencies
  • Implements the agreed upon solution after discussion with other stakeholders
  • Identifies opportunities for, and leads teams for process improvement initiatives
  • Actively participates in risk assessment and development of contingency plans
  • Productive in relevant statistical research and problem solving


Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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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