AbbVie Assistant Director, Statistical Programming in Lake County, Illinois

Description:
The Statistical Programming group is a part of Data and Statistical Sciences (DSS) and is responsible for providing statistical programming services to the Global Pharmaceutical Research and Development division (GPRD). These services are supplied in the context of a cooperative and project-oriented effort with the Global Project Teams (GPTs) and Product Safety teams (PSTs) in the summarization and reporting of data from clinical trials. These services also include the summarization of aggregate data and creation of submission documents to be provided to regulatory agencies. * * * Key Responsibilities: *

  • Provide statistical programming support for multiple clinical projects across multiple therapeutic areas through own effort and staff.
  • Provide training and performance management for staff tables, listings, graphs, narative, creation etc.

    • SAS Programming: *
  • Demonstrated extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry.

  • Demonstrated proficiency in applying SAS programming knowledge to solve problems related to non-routine situations.

    • Standards: *
  • Oversees effort to determine and implement global company standards related to output design and programming conventions.

  • Responsible for monitoring regulatory guidance and industry best practices.
  • Database Activities.

    • Case report forms and database definitions: *
  • Provides strategic guidance on the development of Case Report Forms (CRFs) and database designs.

  • Provides in-depth critical review of global standards related to CRF designs and database designs.

    • Derivation Programming, Submission Data Sets and Programs: *
  • Demonstrated proficiency in interpreting statistical analysis plans and developing analysis data set specifications

  • Oversees effort to determine and implement global company standards related to derive data sets and submission data sets
  • Responsible for monitoring regulatory guidance and industry best practices consultation

    • Client interaction: *
  • Works collaboratively with multiple stakeholders to manage priorities and resources across therapeutic areas.

  • Demonstrates an understanding of drug development principles.

  • Anticipates potential problems within and across projects and develops appropriate contingency plans.

  • Creates escalation plans to ensure resolution of all issues at the therapeutic and project levels.

  • Participates in and is viewed as a key contributor to cross functional initiatives.

    Communication:

  • Effectively and persuasively presents statistical programming concepts, assessment of risks and impacts and logical arguments to other statistical programmers, statisticians, scientists and non-scientists.

  • Effectively presents information through planning and execution of meetings and presentations.

    • Training, Mentoring, Resource Management and Performance Management Training and Mentoring: *
  • Provides appropriate background and motivation to staff.

  • Arranges appropriate training opportunities for staff to facilitate their timely career development.
  • Ensures that self and staff are compliant with training requirements.
  • Effectively mentors statistical programming staff with regard to functional operations.
  • Effectively mentor non-statistical programming peers with regard to statistical programming practices.
  • Provide presentations on statistical programming topics to the statistical programming organization.

    • Resource Management: *
  • Manages statistical programming staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with suitable quality.

    • Allocates resources to projects such that the correct balance of expertise and experience is maintained for all projects: *
  • Works collaboratively with the statistical programming management team to assess project resource requirements versus current staff, including accurate prediction of future workload and adjusts resource assignments to optimize the organizations performance.

  • Recruit and retain statistical programming staff.

    • Performance Management: *
  • Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals.

  • Creates an organization that executes efficiently and is committed to meeting goals.
  • Encourages a culture of open, honest communication where all are encouraged to express their views.
  • Provide all performance management activities for 1-9 statistical programmers.

Qualifications:
Basic :

  • Assistant Director: *

    • Masters Degree in Statistics, Computer Science or a related field with 10 years of relevant experience OR Bachelors Degree in Statistics, Computer Science or a related field with 12 years of relevant experience
    • 2 years of management experience
    • High degree of technical competence and communication ability, both oral and written
    • Highly competent in SAS programming and macro development
    • Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA
    • New Drug Application/Biologic License Application (NDA/BLA) or other regulatory filing experience, including ISS or ISE experience
    • Thorough understanding of ICH Guidelines and relevant regulatory requirements

  • Senior Manager, Statistical Programming: *

    • MS in Statistics, Computer Science or a related field with 8 years of relevant experience OR BS in Statistics, Computer Science or a related field with 10 years of relevant experience
    • High degree of technical competence and communication ability, both oral and written. Competent in SAS programming and Macro development
    • Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience
    • Thorough understanding of ICH Guidelines and relevant regulatory requirements
    • Project lead experience required. Management experience not required
  • Key Leadership Competencies *

    • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
    • Learns fast, grasps the 'essence' and can change the course quickly where indicated
    • Raises the bar and is never satisfied with the status quo
    • Creates a learning environment, opens to suggestions and experimentation for improvement
    • Embraces the ideas of others, nurtures innovation and manages innovation to reality

Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Schedule: Full-time
Shift: Day
Travel: Yes, 5 % of the Time
Req ID: 1701834

Equal Opportunity Employer Minorities/Women/Veterans/Disabled