Senior, Principal Biostatistican / Manager, Biostatsistics - United States
- 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
- Industry internships to 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.