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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.

Manager/Sr. Manager Biostatistics

Irvine, California Req ID 2107818 Category Research and Development Division AbbVie

 

The position is to lead all statistical aspects for clinical studies or a small-scale project within the Medical Aesthetics therapeutic area. As the project statistician for assigned clinical programs, the position represents statistical science on clinical sub-teams advising team members in drug development strategies, plans all aspects of data analysis for assigned projects, has responsibility for the preparation and maintenance of the Statistical Analysis Plan (SAP), and ensures the quality tables, listings and graphs for the clinical document while adhering to the pre-specified analyses and timelines.

This position interacts with domestic and foreign regulatory agencies for AbbVie R&D projects. The position may serve on company and/or departmental teams and make recommendations for departmental standards. The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all AbbVie policies and procedures. 

Qualifications:

This role will be based in Irvine, CA.  A remote, home-based position will be considered by exception only and willl require travel as needed to Irvine, CA based on business needs.

Manager Qualifications:

  • MS in Statistics, Biostatistics, or related fields with at least 4+ years of experience in pharmaceutical statistics required
  • PhD in Statistics, Biostatistics, or related fields with at least 2+ years of experience in pharmaceutical statistics required

Senior Manager Qualifications: 

  • MS in Statistics, Biostatistics, or related fields with at least 6+ years of experience in pharmaceutical statistics required
  • PhD in Statistics, Biostatistics, or related fields with at least 4+ years of experience in pharmaceutical statistics required

Additional:

  • Proven experience managing small-scale projects required - Experience in the submission experience required
  • Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time.

 

 

Significant Work Activities: N/A
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
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