A leading medical technology company are looking for a Senior Biostatistician to join their team in Hayward, CA!
The main function will be to plan the execution of statistical tasks for assigned studies within projects.
This is an initial 12-month Contract averaging 40 hours a week. The chosen candidate will be requested onsite as needed. There will be a flexible workspace arrangement in place.
Some 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
- Proven expertise in MS Office Suite including Word, PowerPoint, and Excel
- Solid understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to Pharmaceutical/Medical Device setting
- Bachelor's Degree in Statistics, Biostatistics or related field
- 5-7 years of experience required