Sr Principal Biostatistician

Job Overview:

Labcorp Drug Development Inc. is looking for a Senior Principal Biostatistician . This is a 100% remote position; can work from anywhere in the U.S.

Domestic travel (1-2%) to attend client meetings and trainings is required.

Job Responsibilities:
  • Lead complex studies such as New Drug Application submission or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings.
  • Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians.
  • Perform project management activities for identified projects including resource planning, timelines and milestone management.
  • Perform complex statistical analyses, quality check statistical analyses developed by other statisticians; and perform complex sample size calculations.
  • Serve as Data Monitoring Committee Support Statistician, developing Data Monitoring Committee Charters and attending Data Monitoring Committee Meetings.
  • Conduct overall statistical review of tables, listings, and figures for complex studies prior to client delivery.
  • Review Case Report Form and other study specific specifications and plans.
  • 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 Clinical Study Report for complex studies.
  • 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.
  • Prepare and review randomization specifications and generation of randomization schedules.
  • 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 New Drug Application submissions or complex, multi-protocol programs in order to win new business.


Required Qualifications:
  • At least a master's degree or its equivalent in Biostatistics or a related field .
  • At least 5 years of experience as a Biostatistician.
  • Demonstrable experience with CDISC standards and CDISC-compliant derived dataset specifications.
  • Demonstrable experience with one or more statistical software packages (SAS) used to conduct statistical analysis.
  • Demonstrable experience with statistical procedures to include non-parametric analysis, linear and non-linear models, categorical data and/or survival analysis.
  • Demonstrable experience with the overall clinical trial process.
  • Demonstrable experience with preparing Statistical Analysis Plans, analysis and reporting across a variety of trials.
  • Demonstrable experience with statistical quality control procedures.


Education/Qualifications:

At least a master's degree or its equivalent in Biostatistics or a related field .

Experience:

  • At least 5 years of experience as a Biostatistician.
  • Demonstrable experience with CDISC standards and CDISC-compliant derived dataset specifications.
  • Demonstrable experience with one or more statistical software packages (SAS) used to conduct statistical analysis.
  • Demonstrable experience with statistical procedures to include non-parametric analysis, linear and non-linear models, categorical data and/or survival analysis.
  • Demonstrable experience with the overall clinical trial process.
  • Demonstrable experience with preparing Statistical Analysis Plans, analysis and reporting across a variety of trials.
  • Demonstrable experience with statistical quality control procedures.


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