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 Clinical Operations.
Responsibilities
- Leads the statistical programming activities for a compound/indication or therapeutic area in early development.
- Leads a team of statistical programmers and manages the resource planning for assigned staff.
- Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
- Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
- Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
- Ensures consistency of ADaM data sets for individual studies and integrated data.
- Creates 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, Statistical Analysts and Senior Statistical Analysts.