ob Summary (Primary function)
The Senior Biostatistician to Senior Manager, Biostatistics is responsible for providing statistical support for drug development programs in all phases of development.
Essential Functions of the Job (Key responsibilities)
- 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 duties, as required.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Ph.D. degree in statistics required.
- Senior Biostatistician: 0 to 3 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics. Principal Biostatistician/Manager, Biostatistics: 2 to 5 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics. Senior Manager: 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.