Orange County Metro Area, CA US
- Develop and execute Statistical Analysis Plans (SAPs) for assigned studies
- Develop statistical specifications to ensure the accuracy of the planned and completed analyses
- Assist in authoring results sections of the clinical study reports and supply statistical input for PMA submissions
- Review protocols and contribute to protocol statistical analysis sections
- Provide independent validation of the statistical content in study documents which may include randomization, study reports, briefing documents, patient brochures, and publications
- Bachelor degree in Statistics, Biostatistics or related field
- 2-4 years of experience required
- Proficiency with R and SAS required
- Solid understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to medical devices
- Proven expertise in MS Office Suite
- $46.75 - $58.43 / hour (Dependent on Experience)
R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal opportunity employer.