Senior Biostatistician / Sr. Manager, Biostatistics - United States
This position is responsible for providing statistical support to drug development programs.
Summary of the Essential Functions of the Job
- Provide statistical input to study protocols
- Develop statistical analysis plan
- Monitor internal and CRO project activities including timelines, deliverables and availability of resources
- Interpret study results and write (or at least QC and review) statistical summary reports of study results
- Assist in writing relevant sections of the clinical study report
- Participate and contribute to Clinical Development Plan
- Participate in pre-IND and NDA activities
- Ph.D. degree in statistics
- One to eight years of experience in pharmaceutical or biotechnology industries with broad knowledge of biostatistics. For the Sr. manager position, a good understanding of FDA/EMEA guidelines and drug development process is required.
- Demonstrated ability to work independently in project management and decision making
- Previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies are highly desirable
- Knowledge of multivariate analyses and Biomarker analyses is a plus
- Be able to effectively communicate his/her ideas and be able to manage programmers in a constructive manner to make other people more effective.
- Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary. This requirement may be waived for research oriented statisticians with demonstrated capabilities of developing and implementing new statistical methods.