The Planet Group
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Summary:
The main function of a biostatistician is to plan the execution of statistical tasks for assigned studies within project
Key Responsibilities:
Additional Skills:
Education and Experience:
**salary will be commensurate with experience**
CO, NY candidates may not be considered.
Prin Biostatistician
Hybrid Location Sacramento, CA 94203 US
Posted: 01/20/2023
2023-01-20
2023-02-25
Employment Type:
Contract To Hire
Job Number: 539421-1
Country: United States
Is job remote?: Yes
Job Description
Summary:
The main function of a biostatistician is to plan the execution of statistical tasks for assigned studies within project
Key Responsibilities:
- 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
- Other duties assigned by Leadership
Additional Skills:
- Proven expertise in MS Office Suite including Word, PowerPoint, and Excel
- Excellent written and verbal communication skills and interpersonal relationship skills
- Keeps abreast of new developments in statistics and regulatory guidance
- Solid understanding and knowledge relevant to theoretical and applied statistics
- Solid understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device setting
- Good problem-solving, organizational, analytical and critical thinking skills
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including the ability to work with vendors and project stakeholders
- Ability to build productive internal/external working relationships
Education and Experience:
- Bachelors Degree in Statistics, Biostatistics or related field
- 8-10 years of experience required
**salary will be commensurate with experience**
CO, NY candidates may not be considered.
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