Principal Biostatistician
Bucharest, Romania
1 zi în urmă

Job Overview :

  • Experienced Principal Biostatistician required to work for Covance
  • Working with multiple Sponsors across several therapeutic areas in all phases of clinical trials (mainly PII & PIII)
  • This is a permanent full-time role, either office based, or home based anywhere in Europe
  • You must have previous experience of working as a Senior Biostatistician in either a biotech, CRO or pharma company within Europe
  • Join our growing team and discover your extraordinary potential by working as a Covance Principal Biostatistician. You will enjoy a varied role working for different sponsors across several therapeutic areas, leading projects and mentoring junior members of the department.

    The position offers an excellent support network with access to Covance’s statistical consultants, flexible working solutions and the opportunity to progress your career.

    If you are looking to strengthen your expertise within a varied and dynamic environment, then this is a fantastic opportunity.

    Job Primary Functions

  • 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, 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
  • Education / Qualifications :

  • Master’s degree, equivalent, or higher in Biostatistics or related field
  • Experience :

  • Previous experience of working as a Principal 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 and of its application within Covance Clinical Development
  • Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials Cooperative, team-oriented and proactive
  • Self-motivation
  • The ability to work to tight deadlines while maintaining high standards
  • Ability to adhere to strict guidelines and codes of practice
  • Ability to explain statistical concepts to non-statisticians
  • Coordination and organizational skills
  • A proactive approach to management of day-to-day activities and actions that may affect Covance as a business
  • A professional approach at all times
  • Ability to motivate others
  • Fluent in English language (both verbal and written).
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