Job Description

The Safety Statistical Programming Senior Manager is a strategic leadership role in the emerging field of safety science, providing programming expertise for development of pooled safety data sets and providing technical guidance to 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 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.

Responsibilities

Lead the statistical programming activities for one or more compounds/indications or therapeutic areas.

Manage a team of statistical programmers and the resource planning for their assigned projects.

Ensure timely deliverables, and that quality processes are followed consistently within the projects.

Harmonize SDTM and non-standard source data across multiple studies, creation and validation of ADaM and TLFs for all safety deliverables following AbbVie’s SOPs, department, and project standards.  

Develop and oversee SAS programs, Product safety data integration plan, metadata, ADaM specifications, ADaM data sets following CDISC standards and Tables, Listings and Figures (TLFs).

Lead initiatives, meetings involving cross functional personnel, external vendors and partner company teams.

Lead the development of data extraction and transformation automation tools, standard SAS Macros and participates in the development of standard operating procedures and cross-functional process improvement initiatives.

Develop and oversee the development of SAS programs for the creation of ADaM data sets following CDISC standards.

Develop and oversee the development of SAS programs for the creation of Tables, Listings and Figures.

Ensure consistency of ADaM data sets for individual studies and integrated data.

Create documentation for regulatory filings including reviewers guides and data definition documents.

Lead the development of standard SAS Macros and the development of standard operating procedures.

Manage, mentor and create career development plans for assigned staff.

Participate in the recruitment and selection of new staff.

Be compliant with training requirements.

This role can be based remotely within the US (#LI-Remote).