
Senior Manager, Statistical Programming - Oncology Early Development
- Chicago, IL
- Permanent
- Full-time
- Leads the statistical programming activities for one or more compounds/indications or a therapeutic area.
- Manages a team of statistical programmers and the resource planning for their assigned projects.
- 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 the development of standard operating procedures.
- Manages, mentors and creates career development plans for assigned staff.
- Participates in the recruitment and selection of new staff.
- 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.
- Minimum of 2 years 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.
- Directors of Statistics
- Data Scientists
- Medical Writers
- Regulatory Publishers
- Clinical Project Managers