The Manager Biostatistics serves as a core team member and leader for larger projects and works in a supervisory capacity, coaching the technical evolution of the work product and reviews client deliverable for compliance with project specifications. In this role, the individual is responsible for both management and technical aspects of development projects. As a technical expert, he/she provides statistical oversight to Sponsor projects with particular emphasis on meeting timelines, keeping budgets on track, and ensuring quality deliverable. The Manager, Biostatistics provides guidance, coaching and development to more junior staff while overseeing the technical evolution of the department work product.
The Manager, Biostatistics:
- 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.