The Senior Principal Biostatistician is responsible for providing statistical support to drug development programs.
- Interact with members of the multidisciplinary project teams to establish project timelines.
- Provide statistical input to study protocols.
- Write statistical analysis plans.
- Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
- Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures.
- Interpret study results and provide review of statistical summary reports of study results for accuracy.
- Assist in writing relevant sections of the clinical study report.
- Participate and contribute to authoring of Clinical Development Plan.
- Participate in pre-IND and NDA activities.
- Participate in the development and enforcement of SOPs and guidelines.
- Other responsibilities as required.
- Ph.D. degree in statistics required.
- 5 to 8 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
- Demonstrate ability to work independently in project management and decision making.
- Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
- Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
- 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.