Manager, 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 .
Purpose: The Manager of Statistical Programming is a strategic role which guides a team of Statistical Programmers in the research and development of new pharmaceutical products. This role is directly responsible for leading the statistical programming activities for a compound/indication or therapeutic area in early development. The Manager of Statistical Programming must effectively interface with Statistics, Data Sciences, 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
- 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.
- Create documentation for regulatory filings including reviewers guides and data definition documents
- Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
- Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.
- MS in Statistics, Computer Science or a related field with 6+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 8+ years of relevant experience.
- In-depth understanding of SAS programming concepts 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.
Significant Work Activities
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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.