Summary
Join AbbVie as a Senior Manager of Statistical Programming and lead a team in the research and development of new pharmaceutical products. This leadership role involves managing statistical programming activities for one or more compounds/indications or a therapeutic area. You will ensure timely deliverables, adherence to quality processes, and consistency across projects. The position requires effective collaboration with various teams, including Statistics, Data Sciences, Medical Writing, Regulatory Publishing, and Development Operations. Responsibilities include developing SAS programs, creating documentation for regulatory filings, and mentoring team members. This hybrid or remote position can be based in any US location.
Requirements
- 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
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
Benefits
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k)
- Short-term incentive programs
- Long-term incentive programs
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