Senior Manager, Safety Statistical Programming Lead

4 weeks ago

Chicago, Illinois, United States AbbVie Full time
About the Role

The 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 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.

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.
  • Develop and oversee 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 reviewer's 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.
Qualifications

Candidates must have an 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).

Qualified candidates will also have the following:

  • A minimum of 2 years' experience leading a team of statistical programmers.
  • In-depth understanding of SAS programming concepts and techniques related to drug development.
  • Experience in leading multi-study data (SDTM/ADaM) integration projects (such as leading submission programming activities involving multiple studies).
  • Experience in leading statistical programming activities supporting IB, DSUR, PSUR, Integrated Summary of Safety (ISS), Annual Safety Reports, and/or other safety analysis.
  • Experience in harmonizing clinical study data from multiple studies with diverse study designs, data standards spanning multiple indications.
  • In-depth understanding of CDISC Standards.
  • In-depth understanding of the drug development process, including experience with regulatory filings.

At AbbVie, we look for strong leadership capabilities and often ask candidates to demonstrate their ability to:

  • Communicate clearly and effectively, including cross-functionally.
  • Build strong relationships with a diverse set of stakeholders.
  • Successfully manage a project (organization, deliverables, expectations).

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