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Senior Manager Biostatistics- Hybrid- Hayward, CA

  • Location: Hayward
  • Salary: Negotiable per hour
  • Job Type:Contract

Posted 19 days ago

  • Sector: Medical
  • Contact: Ben Upton
  • Duration: 12 months
  • Start Date: ASAP
  • Expiry Date: 09 February 2023
  • Job Ref: JN -012023-476324

An innovative medical technology company are actively looking for a Senior Manger in Biostatistics to join their team in Hayward, California. The primary function involves planning the execution of statistical tasks for assigned studies within projects. This is an initial 12-month contract role with room for extension, following a Hybrid work format

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:

  • Bachelor's Degree in Statistics, Biostatistics or related field
  • 10+ years of experience required

Please apply with your most recent resume to be considered for this great opportunity!