Lead Biostatistics Expert for Drug Development

hace 1 mes

All, Gerona, España Daiichi Sankyo Europe A tiempo completo
About the Role

We are seeking a highly skilled Lead Biostatistics Expert to join our team at Daiichi Sankyo Europe. As a key member of our drug development team, you will be responsible for leading statistical support for medium complexity studies, contributing to the development of optimal study designs, and independently developing and executing statistical analysis plans.

Job Description

This role involves working closely with contract research organization (CRO) programmers and statisticians, collaborating with internal programmers in preparing analysis files and performing statistical analyses. You will also interact with study teams, as well as statisticians and programmers at CROs. Additionally, this position works under some supervision to solve complex study problems.

Responsibilities
  • Protocol Development: Develop statistical activities for medium complexity studies, including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation, and CSR input and review.
  • Drug Development Strategy: Provide input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements, and deliver the pre-specified product profile.
  • CRO/Vendor Oversight: Review CRO/vendor proposal and budget, establish procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies.
  • Global Health Authority Interaction/Negotiation: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document.
Requirements

To be successful in this role, you will need:

  • A PhD in statistics or biostatistics
  • 4 or more years of relevant experience in the pharmaceutical industry with a Ph.D.
  • Strong knowledge of statistical methodologies
  • Good understanding of current drug development trends and regulatory environments
  • Excellent programming skills in SAS and/or R and working knowledge of software such as nQuery, East, etc.
  • Strong analytical and problem-solving skills
  • Excellent oral and written communication skills
Salary and Benefits

The estimated salary for this role is €80,000 - €110,000 per annum, depending on experience. In addition to a competitive salary, we offer a comprehensive benefits package, including health insurance, pension scheme, and opportunities for professional development.

Why Work with Us?

At Daiichi Sankyo Europe, we are dedicated to making a difference in the lives of patients. We foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. If you have a proactive mindset and passion for addressing the needs of patients, we encourage you to apply.

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