Principal Biostatistician

My client is an innovating, dynamic and growing international pharmaceutical company, looking for a Principal Biostatistician with a strong experience with SAS programming and CDISC. The Principal Biostatistician is responsible for leading, developing and implementing statistical solutions to clinical trials. Under the guidance of the Head of Biometrics, you will provide leadership role in delivering all statistical support to clinical development program in Zurich or Lausanne.

Your Responsibilities

  • Serve as biostatistics leader for a particular therapeutic indication of a project
  • Participate and interact with clinical and cross-functional teams in the development of protocols, study design and endpoints discussions
  • Develop and review Statistical Analysis Plan (SAP) and provide sample size calculations
  • Lead Biostatistics project management work, including but not limited to: overseeing execution of statistical analyses as per SAP, vendor management, directing statistical programming, mentoring junior statisticians, updating status of project to management on a regular basis, and escalating issues in a timely manner
  • Support NDA/BLA/MAA submission work and generation of ISS/ISE
  • Ensure high quality and timely delivery of tables/figures/listings and statistical reports
  • Prepare or review statistical sections of clinical study report and overall summaries
  • Execute quality assurance procedures on work produced by others, ensuring statistical analysis is being done according to specifications
  • Interact with Regulatory Agencies on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations
  • Provide support for publication
  • Author or review statistical SOPs, guidelines and working instructions
  • Keep apprised of the latest statistical methodologies development related to clinical trials
  • Give statistical presentations to internal/external groups
  • Perform other duties/tasks as required or assigned

Your Profile

  • Minimum of 8 years of industry experience in leading statistical activities as a Biostatistician in supporting clinical trials
  • Experience working on NDA/BLA/MAA submission work and have worked in the planning and generation of ISS/ISE
  • Minimum of 6 years of SAS programming experience and knowledge of CDISC requirements
  • Proficiency in statistical programming in SAS. Knowledge of R and other programming languages is preferred
  • Master’s degree or PhD in Biostatistics or related field
  • Extensive knowledge of statistical methodologies and study designs
  • Experience with regulatory support and interaction
  • Experience in providing vendor oversight
  • Fluent in English

For further information, please contact: Morgane Cayuela: mc@axepta.com

Morgane CAYUELA

Morgane CAYUELA

Life Sciences Recruitment Specialist

Noémie OLIVA

Noémie OLIVA

Team Leader & Recruitment Management Life Sciences

Marine DOLLAT

Marine DOLLAT

Life Sciences Recruitment Specialist

Principal Biostatistician

Dec 14, 2021Principal BiostatisticianLausanne Zurich Full Time Permanent Job mc@axepta.com Life Sciences

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