Lead/Principal Biostatistician
Minimum Work Experience:
6+ years of Pharma/CRO Industry as Biostatistician with M.Sc. / PhD in Statistics/Biostatistics
Preferred Skills:
- M.Sc. /PhD in Statistics/Biostatistics
- Extensive experience in statistical design and analysis methodology of basic and complex studies.
- Extensive experience in leading statistical activities in clinical research.
- Experience with regulatory submissions and support preferred.
- Excellent verbal and written communication.
- Proven ability to effectively communicate statistical concepts.
Key Responsibilities:
- Serve as primary statistical representative for biometrics projects. Provide Statistical Strategy Consulting to Clients.
- Responsible for producing and coordinating the production of analysis plans, statistical output, and study reports for clinical trial programs, as well as the evaluation of study protocols.
- Effectively manage broad based projects such as NDA submissions or complex, multi protocol programs, potentially coordinating activities across multiple locations.
- Ensures all work is processed on time to appropriate quality levels and provide broad statistical support to non-biostatisticians within the company.
- Work independently in the quality control of analysis plans, reports derived datasets, tables, listings, figures and any other statistical deliverables.
- Expected to have an understanding of advanced statistical methods and to research complex and innovative statistical approaches (e.g, modeling and simulation, adaptive design / Bayesian statistics) and mentor junior staff in the use of these approaches.
- Represent department and company in a multidisciplinary setting, including project team meetings and client meetings/presentations.
Job Type: Full Time