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Prin Biostatistician

Sacramento, CA 94203

Posted: 01/26/2023 Employment Type: Contract To Hire Job Category: Data Sciences Job Number: 539421 Is job remote?: Yes Country: United States

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
77-87 pay rate range
**salary will be commensurate with experience**
CO, NY candidates may not be considered.
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