An amazing medical technology company are looking for an experienced Principle Biostatistician to join their team in Hayward, California!
This is an initial 12 month contract with the possibility to extend. The role will be a hybrid arrangement and needs to be filled ASAP.
Key responsibilities and requirements
- Develop and execute Statistical Analysis Plans (SAPs) for assigned studies
- Develop statistical specifications as necessary to ensure the accuracy of the planned and completed analyses or basic exploratory analyses
- Assist in authoring results sections of the clinical study reports and supply statistical input for PMA submissions and in response to regulatory questions
- Review and assist in the development of protocols and contribute to protocol statistical analysis sections, and may generate study randomization scheme when appropriate
- Provide independent validation of the statistical content in study documents and may include randomization, study reports, briefing documents, patient brochures, and publications
- Solid understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device setting
- Must be able to work in a team environment, including the ability to work with vendors and project stakeholders
Education and Experience:
- Bachelor's Degree in Statistics, Biostatistics or related field
- 8-10 years of experience required
Please, apply with your most up-to-date resume to be considered.