Title: Manager, Biostatistics
Type: Permanent Role
Notes: No Corp to Corp
- Independently develops SAS programs to generate listings, tables and figures as outlined by a statistical analysis plan and to generate randomization codes
- Performs QC of TLFs, CDISC and other analysis data sets
- Prepares specifications for CDISC and other analysis data sets
- Independently develops statistical analysis plans
- Acts as Lead Biostatistician to interact with the study team and the Sponsor
- Supports Business Development by preparing for and attending bid defense meetings, preparing capabilities presentations, and assisting with budget and proposal development.
- Acts as an independent Biostatistician on DSMBs and DMCs
- Acts as Project Manager for one Biostatistics stand-alone project, and completes consultancy work as needed
- Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop the team structure
- Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field
- 10 years of experience in clinical trials design and analysis using SAS
- 2 to 5 years of experience as supervisor/manager
- Prior experience using computerized information systems preferred.
- Ability to read, write, and speak fluent English; fluent in host country language.
- Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
- Works with internal and external customers/vendors to meet project specific goals.
- Identifies, monitors, documents, and tracks out-of-scope activities.