Associate Director, Statistical Programming
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.
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.
appropriate contingency plans. Creates escalation plans to ensure resolution of all issues at the therapeutic and project levels.
arguments to other statistical programmers, statisticians, scientists and non-scientists.
facilitate their timely career development.
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
Yes, 5 % of the Time
Job Level Code
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.