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AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

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Senior Director, and Statistics Therapeutic Area Head, Virology/General Medicine

📁
Regulatory Affairs
📅
1900179 Requisition #

The Senior Director, and Statistics Therapeutic Area Head leads all statistics activities related to development and associated submissions with these TAs. This leader guides an organization of statisticians responsible for development/submission strategy and clinical trial methodology. A highly empowered, visible and collaborative role, the Statistics TA Head partners with, clinical and regulatory experts to advance medicines to our patients.

 

Job Responsibilities

·        Set the vision for the statistics TA through building and maintaining a best-in-class organization. Maintain and establish (as needed) expertise in diseases within the TA.

·        Provide operational, strategic, and technical direction to product and project level statisticians with ultimate responsibility for all statistical deliverables within the TA.

·        Ensure the TA provides scientifically sound development strategies that incorporate both current best practices and innovative approaches. Propose and implement optimal methodologies including accelerated or seamless designs. Support the development and validation of new clinical endpoints to support approval.

·        Maintain a strong external presence within the statistics community by representing abbvie on advanced and emerging topics. Attend key conferences and workshops in support of the presentation of company data, and the evaluation of scientific data presented across industry and academia.

·        Represent abbvie at key regulatory meetings and/or FDA advisory committee meetings or deploy qualified staff as appropriate.

·        Serve in the Data and Statistical Sciences Senior Leadership Team to provide guidance on direction and operations of the department as a whole, and to protect and preserve the abbvie culture.

·        Ensure proper precision medicine strategies and methods.

·        Content owner of TA specific data, analysis and reporting standards.

 

·        PhD in statistics or related field with 13+ years of experience in the pharmaceutical or biotechnology industry.

·        Experience leading development programs through submission and approval. Previous experience within the TA is required.

·        Experience building and leading high performing teams; and identifying, attracting, developing, and retaining top talent.

·        Demonstrated expertise in advanced statistical methods (e.g. Adaptive designs, Bayesian methods, multiplicity, subgroup identification, precision medicine etc.).

·        Excellent understanding of FDA/EMA guidance within the TA.

·        Ability to communicate with clarity and influence to executives, regulators and key stakeholders.

·        Experienced negotiator with excellent judgment around compromising, standing firm, or finding a new way forward.

·        Leadership acumen including emotional intelligence and business awareness. Ability to effectively collaborate and influence throughout multiple levels of the organization.

·        Demonstrated external presence via activities within the statistical/drug development community and publication record.

 

Key Stakeholders

·        Clinical Development TA Heads

·        Regulatory Affairs TA leadership

 

 

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

 

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