AbbVie - North Chicago, IL
posted 5 months ago
The Safety Statistical Programming Senior Manager is a strategic leadership role in the emerging field of safety science, providing programming expertise for the development of pooled safety data sets and offering technical guidance to a team of Statistical Programmers in the research, development, and safety assessment of pharmaceutical products. This role is directly responsible for leading the statistical programming activities for the development and maintenance of integrated clinical safety data for multiple compounds and indications. The Senior Manager of Statistical Programming (Safety) must effectively interface with team members from Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing, and Clinical Operations. In this position, the Senior Manager will lead the statistical programming activities for one or more compounds/indications or therapeutic areas. They will manage a team of statistical programmers and oversee resource planning for their assigned projects, ensuring timely deliverables and adherence to quality processes within the projects. The role involves harmonizing SDTM and non-standard source data across multiple studies, as well as the creation and validation of ADaM and TLFs for all safety deliverables, following AbbVie's SOPs, department, and project standards. The Senior Manager will develop and oversee SAS programs, product safety data integration plans, metadata, ADaM specifications, and ADaM data sets following CDISC standards. They will also lead initiatives and meetings involving cross-functional personnel, external vendors, and partner company teams. Additionally, the role includes leading 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 Senior Manager will create documentation for regulatory filings, manage, mentor, and create career development plans for assigned staff, and participate in the recruitment and selection of new staff. Compliance with training requirements is also a key aspect of this role.