Principal Biostatistician (FSP) at Labcorp Drug Development

Job Primary Functions

• Lead complex studies such as NDA submissions 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, under direction of Statistical Consultants
• 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 under the supervision of more senior statistical staff
• Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant
• Provide statistic 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, multi-protocol 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.

Job Qualifications

• Master’s degree, equivalent, or higher in Biostatistics or related field
• Previous experience of working as a Lead Biostatistician in either a biotech, CRO or pharma company.
• 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
• Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials
• Fluent in English language (both verbal and written).