
Manager, Statistical Programming - REMOTE
- Jersey City, NJ
- Permanent
- Full-time
- 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.
- 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.