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Senior Statistical Analyst

2 months ago

East Irvine, United States AbbVie Full time


Company Description

 

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.


Job Description

 

 

The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clinical studies and projects with lower complexity. The Senior Statistical Analyst interfaces with key stakeholders (i.e. Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations.)

 

Responsibilities:

  • Leads the statistical programming activities for projects with lower complexity.
  • Leads the statistical programming activities for studies.
  • Create documentation for regulatory filings including reviewers guides and data definition documents.
  • Leads the development of standard SAS Macros.
  • Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.
  • Develop SAS programs for the creation of ADaM data sets following CDISC standards.
  • Develop SAS programs for the creation of Tables, Listings and Figures.
  • Validation of ADaM data sets, Tables, Listings and Figures.
  • Create specifications for the structure of ADaM data sets for individual studies and integrated data.
  • Participates in the development of standard operating procedures.

    The Senior Statistical Analyst roles have the flexibility to be based remotely within the US.


    Qualifications

     

    • MS in Statistics, Computer Science or a related field with 5+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 7+ years of relevant experience.
    • In-depth understanding of SAS programmingconcepts and techniques related to drug development.
    • Fundamental understanding of CDISC Standards.
    • Fundamental understanding of the drug development process, including experience with regulatory filings.
    • Ability to communicate clearly both oral and written.
    • Ability to accurately estimate effort required for study related programming activities.


      Additional Information

       

       

      Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

       

      • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
        • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
        • This job is eligible to participate in our short-term incentive programs.

          Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion, consistent with applicable law.

          All your information will be kept confidential according to EEO guidelines.

          AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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 protected veteran, or any other legally protected group status.