Description
An exciting opportunity in South San Francisco recently became available. The Sr. Manager/Associate Director Biostatistics provides leadership and guidance as the statistical expert on a project team or within a therapeutic area. For one or more projects, be accountable for all statistical aspects of protocols and submissions, including quality, relevance to regulatory perspective, and scientific validity. This is a full-time and onsite position.Detailed Job Description:
- With minimal direction from departmental management, assume leadership role for providing statistical support to one or more project teams.
- Interact with the clinical / regulatory functions to define study endpoints and perform relevant sample size calculations.
- Learn key clinical and regulatory considerations, ensure that planned statistical methods are applicable, and communicate important statistical considerations cross-functionally.
- Effect consistency of data collection and analysis within project.
- Oversee production of the statistical analyses according to SAP and oversee preparation of the statistical methods and results sections for CSR and overall summaries.
- Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package.
Requirements:
- Ph.D. in statistics
- 8-10+ years of experience in the biotechnology or pharmaceutical
- Excellent verbal, written & presentation skills
- Broad knowledge and superior understanding of advanced statistical concepts and techniques
This is an opportunity to join a highly motivated and forward thinking Biometrics team. Competitive salary and benefits available to position holder.
To find out more about Real please visit www.realstaffing.com