Loading ...
Loading ...
Sr. Principal Biostatistician
View: 198
Update day: 22-04-2024
Category: R & D IT - Software
Industry: Biotechnology Hospital & Health Care Pharmaceuticals
Position: Mid-Senior level
Job type: Full-time
Loading ...
Job content
SummaryThe Senior Principal Biostatistician is responsible for providing statistical support to drug development programs.
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 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.
Loading ...
Loading ...
Deadline: 06-06-2024
Click to apply for free candidate
Report job
Loading ...
Loading ...
SIMILAR JOBS
-
⏰ 05-05-2024🌏 Yverdon-les-Bains, Vaud VD
-
⏰ 07-05-2024🌏 Lausanne, Vaud VD
-
⏰ 04-05-2024🌏 Vevey, Vaud VD