AbbVie
Senior Manager, Statistical Programming (Remote)
AbbVie, Irvine, California, United States, 92713
Company DescriptionAbbVie'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 DescriptionThe Senior Manager of Statistical Programming is a leadership role which manages a team of statistical programmers in the research and development of new pharmaceutical products. The Senior Manager of Statistical Programming is responsible for leading the statistical programming activities for one or more compounds/indications or a therapeutic area. This role must effectively interface with key stakeholders (i.e. Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations).
Responsibilities:
Leads the programming activities for multiple compounds/indications and therapeutic areas.
May lead a team of programmers and manage the resource planning for assigned staff.
Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
Creates documentation for regulatory filings including reviewers guides and data definition documents.
Leads the development of standard SAS Macros and the development of standard operating procedures.
Manages, mentors and creates career development plans for assigned staff, as applicable.
Participates in the recruitment and selection of new staff.
Participates in and is viewed as a key contributor to cross functional initiatives.
Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
Ensures consistency of ADaM data sets for individual studies and integrated data.
Qualifications:
MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.
Previous experience providing mentorship for more junior statistical programmers.
In-depth understanding of SAS programming concepts and techniques related to drug development.
In-depth understanding of CDISC Standards.
In-depth understanding of the drug development process, including experience with regulatory filings.
Ability to communicate clearly both orally and in writing.
Ability to effectively represent the Statistical Programming Organization in cross functional teams.
Ability to accurately estimate effort required for project related programming activities.
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Job DescriptionThe Senior Manager of Statistical Programming is a leadership role which manages a team of statistical programmers in the research and development of new pharmaceutical products. The Senior Manager of Statistical Programming is responsible for leading the statistical programming activities for one or more compounds/indications or a therapeutic area. This role must effectively interface with key stakeholders (i.e. Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations).
Responsibilities:
Leads the programming activities for multiple compounds/indications and therapeutic areas.
May lead a team of programmers and manage the resource planning for assigned staff.
Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
Creates documentation for regulatory filings including reviewers guides and data definition documents.
Leads the development of standard SAS Macros and the development of standard operating procedures.
Manages, mentors and creates career development plans for assigned staff, as applicable.
Participates in the recruitment and selection of new staff.
Participates in and is viewed as a key contributor to cross functional initiatives.
Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
Ensures consistency of ADaM data sets for individual studies and integrated data.
Qualifications:
MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.
Previous experience providing mentorship for more junior statistical programmers.
In-depth understanding of SAS programming concepts and techniques related to drug development.
In-depth understanding of CDISC Standards.
In-depth understanding of the drug development process, including experience with regulatory filings.
Ability to communicate clearly both orally and in writing.
Ability to effectively represent the Statistical Programming Organization in cross functional teams.
Ability to accurately estimate effort required for project related programming activities.
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