AbbVie

Associate Director, Statistical Programming

Employer
AbbVie
Location
Madison, New Jersey
Posted
Apr 20, 2021
Ref
2106349
Required Education
Bachelors Degree
Position Type
Full time
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.

Purpose

Provide statistical programming support for multiple clinical projects across multiple therapeutic areas through own effort and those of their staff. Provide training and performance management for staff.The Senior Manager demonstrates leadership competencies, builds relationships and promotes teamwork within the statistical programming organization and across functions. Accountable for providing Statistical Programming support for multiple therapeutic areas. Responsible for making key recommendations and decisions related to processes, standards and resource management. Responsible for management and development of staff.

 

Responsibilities

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. Case report forms and database definitions: Provides strategic guidance on the development of 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 subm
  • 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.
  • 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 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.
  • 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
  • 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 4-10 statistical programmers
    Qualifications

    Qualifications:

    MS in Statistics, Computer Science or a related field with 10+ years of relevant experience. OR BS in Statistics, Computer Science or a
    related field with 12+ years of relevant 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. NDA/BLA or other regulatory filing experience, including ISS or ISE experience. Thorough understanding of ICH Guidelines and
    relevant regulatory requirements. A minimum of 2 yrs management experience required.
    Significant Work Activities
    N/A
    Travel
    Yes, 5 % of the Time
    Job Type
    Experienced
    Schedule
    Full-time
    Job Level Code
    M
    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.