Senior Principal Biostatistician
Covance
Barcelona, Spain
hace 6 días

Job Overview :

  • Experienced Senior Principal Biostatistician required to work within Covance’s Statistical Analysis Research Centre
  • You will Lead in the design and consult on complex studies and multi-protocol programs as well as Leading the DMC process
  • Previous experience of supporting data monitoring committees essential
  • This is a permanent full-time role, either office based, or home based anywhere in Europe
  • Join our growing team and discover your extraordinary potential by working as a Covance Senior Principal Biostatistician within our SARC (Statistical Analysis Research Centre) team.

    The SARC team is a service group within Covance that can provide statistical expertise, statistical consulting, or independent statistical review for clinical protocol design to regulatory submissions.

    Within the SARC team, we have very talented set of individuals with many years of statistical and pharmaceutical expertise in all phases of clinical development and several therapeutic areas.

    Job Primary Functions

  • Lead in the design and consult on complex studies and multi-protocol programs. Providing statistical oversight and attending relevant project meetings
  • Lead the DMC process and management and serve as DMC Support Statistician as project manager including the development of DMC Charters, attending DMC Meetings, and writing DMC Meeting minutes
  • Perform project management activities for identified projects including resource planning, timelines and milestone management
  • Lead the development of complex Statistical Analysis Plans. Perform senior review of statistical analysis plans developed by other statisticians.
  • Provide statistical support as a consultant for complex study designs as required

  • 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
  • Perform sample size calculations
  • Develop the statistical sections of the protocol for complex studies. Provide input as necessary as a Statistical Consultant
  • Provide statistic input and review of the CSR for complex studies
  • Preparation and review of randomization specifications and generation of randomization schedule
  • 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
  • Education / Qualifications :

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

  • Demonstrate good knowledge in supporting data monitoring committees with excellent organizational skills, communication skills and writing skills
  • 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
  • Full knowledge of the interactions required by a biostatistician throughout the lifespan of a trial; a good knowledge of the responsibilities of those departments with whom biostatisticians and statistical programmers interact
  • Strong supervisory skills, and ability to organize their own and others' work
  • Excellent problem solving skills, and a willingness to take ownership of decision-making
  • Interpersonal and effective communication skills; able to communicate appropriately throughout Covance and with its clients
  • A substantial knowledge of the overall clinical trial process
  • A broad up-to-date knowledge of statistics as applied in clinical trials across therapeutic areas and to complex statistical methods (including adaptive design and platform trial design)
  • Demonstrates good knowledge of clinical research guidance, including Food and Drug Administration (FDA), international regulatory agencies, international conference on harmonization (ICH), and good clinical practice (GCP).
  • Fluent in English language (both verbal and written)
  • PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSE

    NO AGENCIES PLEASE

    MORE INFORMATION AVAILABLE ON REQUEST

    For a confidential discussion about this opportunity, please phone Peter Lewis on +44 (0) 1628 543 457. To apply, please click on the APPLY button.

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