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
- Leads 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 datasets 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 Analysis the statistical programming activities for a compound/indication or therapeutic area in early development.
- MS in Statistics, Computer Science or a related field with 8+ years of relevant experience.
- OR BS in Statistics, Computer Science or a related field with 10+ years of relevant experience.
- Previous experience leading a team of statistical programmers.
- In-depth understanding of SAS programming concepts and techniques related to drug development.
- In-depth understanding of CDISC Standards.
- In-depth understanding of the drug development process, including experience with regulatory filings.
- Ability to communicate clearly both oral and written.
- Ability to effectively represent the Statistical Programming Organization in cross functional teams.
- Ability to accurately estimate effort required for project related programming activities.
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Zakres pracy: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Rodzaj pracy: Experienced