Jobs · Quality Assurance

Clinical Biostatistician, Early Phase

Bayside Solutions · San Mateo County, CA · 1 wk ago
RemoteRemoteQuality Assurance$90–$100/hrContract

W2 contract role.

Pay

$90 - $100 per hour

Location

Redwood City, CA - Remote Role

About the role

This position serves as a lead or supporting statistician for early-phase oncology studies and coordinates activities with other functional groups to ensure timely deliverables.

Responsibilities

  • Provide statistical expertise for the design, analysis, and reporting of clinical studies.
  • Develop statistical analysis plans and analysis specifications.
  • Conduct and/or perform QC on statistical analyses, including statistical modeling, as needed.
  • Collaborate with the statistical programmer team to ensure that analysis is conducted per statistical plan and specifications.
  • Collaborate with data management and clinical operations to ensure robust CRF and database development and quality data collection.
  • Contribute to the development and review of publications and regulatory documents, and ensure consistency and accuracy in data presentation.
  • Represent biostatistics on study teams.

Requirements

  • Ph.D. or M.S. in statistics or biostatistics, with a minimum of 5 years (for Ph.D.) or 8 years (for M.S.) of experience in the biotech/pharmaceutical industry as a statistician.
  • Solid tumor drug development experience is required.
  • Experience with early development clinical studies is desirable.
  • Proficiency in SAS and/or R.

Skills

  • Ability to work independently and within a team.
  • Excellent verbal and written communication skills.
  • Good interpersonal and project management skills.

Desired Experience

  • Biostatistics
  • Early-Phase Oncology Studies
  • Solid Tumor Drug Development
  • Clinical Study Design
  • Statistical Analysis
  • Statistical Modeling
  • Statistical Analysis Plans
  • Analysis Specifications
  • Statistical Quality Control
  • Statistical Programming Collaboration
  • CRF Development
  • Clinical Database Development
  • Data Quality
  • Clinical Data Management
  • Clinical Operations
  • Regulatory Documents
  • Scientific Publications
  • Data Presentation
  • Cross-Functional Collaboration
  • Study Team Representation

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