Manager, Statistical Programming

Employer
AbbVie
Location
Lake County, IL, US
Posted
Sep 04, 2019
Ref
1905787
Required Education
Masters Degree/MBA
Position Type
Full time
Purpose:
The Manager of Statistical Programming is a strategic role which guides a team of Statistical Programmers in the research and development of new pharmaceutical products. This role is directly responsible for leading the statistical programming activities for a compound/indication or therapeutic area in early development. The Manager of Statistical Programming must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations.

Responsibilities:

  • Leads the statistical programming activities for projects with lower complexity.
  • Leads the statistical programming activities for studies
  • Develop SAS programs for the creation of ADaM data sets following CDISC standards
  • Develop SAS programs for the creation of Tables, Listings and Figures.
  • Validation of ADaM data sets, Tables, Listings and Figures.
  • Create specifications for the structure of ADaM data sets for individual studies and integrated data.
  • Create documentation for regulatory filings including reviewers guides and data definition documents
  • Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
  • Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts.


Level will be based on education & years of experience.

Basic:

  • MS in Statistics, Computer Science or a related field with 6+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 8+ years of relevant experience.
  • In-depth understanding of SAS programming concepts and techniques related to drug development.
  • Fundamental understanding of CDISC Standards.
  • Fundamental understanding of the drug development process, including experience with regulatory filings.
  • Ability to communicate clearly both oral and written.
  • Ability to accurately estimate effort required for study related programming activities.