Principal Biostatistician

vor 3 Monaten


Essen, Deutschland SEC Life Sciences Vollzeit

Are you an experienced biostatistician passionate about leading top-quality clinical research? We are representing a client who has an excellent permanent opportunity for a Lead Biostatistician. This role involves overseeing biostatistics study activities, ensuring projects are completed on time and within budget, and collaborating with internal and external partners to enhance statistical methodologies.

The successful candidate will join a dynamic organisation dedicated to pushing the boundaries of healthcare through innovative clinical research and development. If you have a robust background in biostatistics and thrive in a collaborative work environment, this role could be ideal for you.



Key Responsibilities as Lead Biostatistician

  • Oversee biostatistics study activities with minimal supervision, supporting both research and non-research functions.
  • Serve as the primary statistical point of contact for assigned study activities, particularly in cross-functional study teams.
  • Contribute to study protocol development, including study design, sample size calculation, and statistical analysis planning.
  • Develop Statistical Analysis Plans (SAP) and oversee statistical analysis deliverables with the programming team.
  • Ensure accurate interpretation of statistical results and provide insights for reporting, including Clinical Study Reports (CSR).
  • Support Medical Affairs and Health Economics Outcomes Research (HEOR) strategies by setting up additional statistical analyses as needed.
  • Coordinate with statistical programmers for the development and execution of analyses.
  • Act as a subject matter expert in meetings or teleconferences with health authorities.



Required Experience and Qualifications

  • Master's degree or PhD (preferred) in statistics, mathematics, or a related field.
  • Minimum of 5 years of experience as a statistician in drug development, clinical research, pharmaceutical companies, Contract Research Organisations (CROs), or medical device settings.
  • Experience in oncology and/or late-phase projects is a plus.
  • Strong knowledge of major statistical methods and industry standards.
  • Proficiency in working with CDISC standards and statistical software such as SAS and R.
  • Deep understanding of the principles, concepts, methods, and standards of clinical research.
  • Excellent communication skills, with the ability to explain complex statistical concepts in simple terms.
  • Demonstrated leadership, entrepreneurial spirit, and proactive problem-solving abilities.

Apply now for immediate consideration, or contact us directly to explore similar opportunities in the field.