Senior Manager, Safety Statistical Programming Lead
4 weeks ago
AbbVie is a leading biopharmaceutical company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. We are seeking a highly skilled Safety Statistical Programming Senior Manager to join our team.
This role is a strategic leadership position in the emerging field of safety science, providing programming expertise for the development of pooled safety data sets and technical guidance to a team of Statistical Programmers. The Senior Manager will lead the statistical programming activities for the development and maintenance of integrated clinical safety data for multiple compounds and indications.
The ideal candidate will have a strong background in SAS programming concepts and techniques related to drug development, as well as experience in leading multi-study data integration projects. They will also have a deep understanding of CDISC standards and the drug development process, including experience with regulatory filings.
The Safety Statistical Programming Senior Manager will be responsible for:
- Leading the statistical programming activities for one or more compounds/indications or therapeutic areas.
- Managing a team of statistical programmers and resource planning for their assigned projects.
- Ensuring timely deliverables and quality processes are followed consistently within the projects.
- Harmonizing SDTM and non-standard source data across multiple studies, creating and validating ADaM and TLFs for all safety deliverables following AbbVie's SOPs, department, and project standards.
- Developing and overseeing SAS programs, product safety data integration plans, metadata, ADaM specifications, ADaM data sets following CDISC standards, and Tables, Listings, and Figures (TLFs).
- Leading initiatives, meetings involving cross-functional personnel, external vendors, and partner company teams.
- Developing and overseeing the development of data extraction and transformation automation tools, standard SAS Macros, and participating in the development of standard operating procedures and cross-functional process improvement initiatives.
The Safety Statistical Programming Senior Manager will also be responsible for ensuring consistency of ADaM data sets for individual studies and integrated data, creating documentation for regulatory filings, including reviewer guides and data definition documents, and leading the development of standard SAS Macros and standard operating procedures.
This role can be based remotely within the US and offers a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. The company is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
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Chicago, Illinois, United States AbbVie Full timeJob Title: Senior Manager, Safety Statistical ProgrammingAbbVie is seeking a highly skilled Senior Manager, Safety Statistical Programming to lead our statistical programming activities for the development and maintenance of integrated clinical safety data for multiple compounds and indications.Job SummaryThe Senior Manager, Safety Statistical Programming...
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Chicago, Illinois, United States AbbVie Full timeAbout the RoleThe Senior Manager, Safety Statistical Programming is a strategic leadership position in the emerging field of safety science, providing programming expertise for the development of pooled safety data sets and technical guidance to a team of Statistical Programmers in the research, development, and safety assessment of pharmaceutical...
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