Senior Principal Biostatistician

Job Overview:

  • Lead complex studies such as NDA submission or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings
  • Perform project management activities for identified projects including resource planning, timelines and milestone management
  • Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings
  • Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians
  • Perform complex statistical analyses, quality check statistical analyses developed by other statisticians
  • Conduct overall statistical review of TFLs for complex studies prior to client delivery
  • Review CRF and other study specific specifications and plans
  • Perform complex sample size calculations
  • Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant/Statistical Fellows
  • Provide statistical input and review of the CSR for complex studies
  • Preparation and review of randomization specifications and generation of randomization schedules
  • Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures
  • Present and share knowledge at monthly seminars and /or team meetings and at external scientific meetings and conferences
  • Attend bid defense meetings for complex studies such as NDA submissions or complex, multiprotocol programs in order to win new business
  • Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives
  • Represent the department during audits


Education/Qualifications:

  • Recommended: Master's degree, equivalent, or higher in Biostatistics or related field
  • Minimum Required : Bachelor's degree, equivalent, or higher in Biostatistics or related field


Experience:

Minimum Required:
  • 10+ years of experience or an equivalent combination of education or experience to successfully perform the key responsibilities of the job
  • Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses. SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
  • Proven ability to effectively communicate statistical concepts
    A good knowledge of the overall clinical trial process and of its application within Labcorp Drug Development
  • Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials


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