Senior Manager - Statistical Programming
Company Description
AbbVie'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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The 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 Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations.
Responsibilities
Manages a team of statistical programmers and the resource planning for their assigned projects.
Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
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.
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.
Participates in the recruitment and selection of new staff.
Key Stakeholders
• Directors of Statistics • Data Scientists • Medical Writers • Regulatory Publishers • Clinical Project Managers
Qualifications
*This position can be hybrid at any of our US locations or work remotely US*
Minimum 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.
Minimum of 2 years experience leading a team of 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 oral and written.
Ability to effectively represent the Statistical Programming Organization in cross functional teams.
Ability to accurately estimate effort required for project related programming activities.
Additional Information
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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Senior Manager - Statistical Programming
Company Description
AbbVie'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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The 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 Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations.
Responsibilities
Manages a team of statistical programmers and the resource planning for their assigned projects.
Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
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.
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.
Participates in the recruitment and selection of new staff.
Key Stakeholders
• Directors of Statistics • Data Scientists • Medical Writers • Regulatory Publishers • Clinical Project Managers
Qualifications
*This position can be hybrid at any of our US locations or work remotely US*
Minimum 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.
Minimum of 2 years experience leading a team of 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 oral and written.
Ability to effectively represent the Statistical Programming Organization in cross functional teams.
Ability to accurately estimate effort required for project related programming activities.
Additional Information
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html