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Statistical Expert for Oncology and Infectious Disease Trials

vor 1 Woche


Lausanne, Waadt, Schweiz Debiopharm Vollzeit

We are looking for a talented individual to lead our biostatistics efforts in clinical development. As a Clinical Development Principal Biostatistician at Debiopharm, you will play a critical role in shaping the biostatistical strategy for our clinical studies and ensuring the highest level of statistical quality.

In this role, you will have the opportunity to collaborate with cross-functional teams to drive biostatistical methodologies and contribute towards the successful development of our innovative medicines. You will be responsible for developing and overseeing the biostatistical plan for clinical studies across all phases of development.

Your key responsibilities will include:

  • Developing and reviewing statistical analysis plans (SAPs) to ensure appropriateness of statistical methodologies
  • Collaborating with clinical teams to define clinical study design, endpoint definitions, and analysis strategies
  • Leading the statistical programming activities and ensuring timely delivery of statistical outputs, including tables, figures, and listings (TFLs)
  • Communicating statistical findings effectively to cross-functional teams and stakeholders
  • Developing and implementing best practices and standard operating procedures for biostatistics
  • Ensuring compliance with regulatory requirements and industry guidelines

Requirements:

  • Masters or PhD in Biostatistics, Statistics, Mathematics, or a related field
  • At least 6-8 years of experience in biostatistics within the pharmaceutical or biotechnology industry
  • Proficient in statistical programming using SAS or R, with substantial experience in clinical trial analysis
  • Strong knowledge of regulatory guidelines, including ICH, GCP, and FDA regulations
  • Experience in clinical trial design and analysis for Oncology and/or Infectious Disease studies is highly desirable
  • Excellent analytical, problem-solving skills, and attention to detail
  • Strong communication skills in English, with the ability to convey complex statistical concepts to non-statisticians
  • A proactive team leader with a proven record of delivering results in a fast-paced environment