Principal Statistician - Oncology

Principal Statistician - Oncology

BioNTech

Mainz, Germany

At BioNTech, you will be responsible for the implementation of mathematical concepts and statistical models in clinical research projects as well as participation in strategy and team development.

Your duties in detail:

  • Represent statistics in cross-functional project and study teams in multiple projects
  • Provide statistical input into Clinical Development Plans, Clinical Study Protocols, Clinical Study Reports, regulatory submission documents, and publications ensuring accurate deliverables
  • Perform sample size calculations, develop statistical analysis plans and support TLF development
  • Perform statistical analyses and validate analysis results
  • Oversee outsourced statistical CRO activities and deliverables ensuring highest quality in a timely manner
  • Develop, implement and improve statistical processes and standards (SOPs)
  • Support and participate in the development of departmental strategies
  • Provide support and day-to-day team development as a subject-matter-expert (SME)

What you have to offer:

  • University degree (MSc/PhD) in statistics or mathematics and at least 10 years of relevant experience in biostatistics in pharmaceutical industry and/or CRO
  • Experience with clinical drug development and clinical trials in oncology and excellent knowledge of clinical study designs and statistical methods
  • Knowledge in innovative adaptive designs is desired as well as excellent knowledge of relevant regulatory guidelines (ICH, FDA, EMA)
  • Adaptability to rapidly changing organizational and business environment; Awareness of the bigger picture and innovative and solution orientated thinking
  • Attention to detail with a strong orientation to quality, fluent English language skills and very good oral and written communication skills required; Ability to communicate fluently in German highly preferred
  • Experience with SAS required; EAST software experience preferred
  • Experience with regulatory/governmental registrations and submissions preferred

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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