Safety Expert Statistician

vor 2 Wochen

Frankfurt am Main, Hessen, Deutschland AL Solutions Vollzeit
Senior Safety Expert Statistician

AL Solutions is seeking a highly experienced Senior Safety Expert Statistician to join our team in Germany. As a key member of our safety team, you will play a critical role in ensuring the safety of our pharmaceutical products.

Main Responsibilities:
  • Lead the detection, validation, and characterization of safety signals for multiple projects, working closely with the group head.
  • Provide statistical support and scientific leadership for clinical trial safety data, collaborating with project teams.
  • Develop and track project timelines and resource allocation for safety-related activities, promoting effective teamwork.
  • Contribute to the development of quality standards for individual trials and across therapeutic areas, ensuring harmonization and consistency.
  • Mentor junior staff, providing technical guidance and support to ensure their growth and development.
  • Collaborate with other functions in the safety monitoring team and with statistics project leaders, ensuring effective communication with senior leadership.
  • Represent statistics in scientific working groups and cross-functional initiatives, leading when applicable.
Requirements:
  • PhD/MS in statistics or a related field, with a strong background in clinical development or post-marketing activities.
  • Broad experience in safety signal detection, submissions, and interactions with regulatory agencies.
Soft Skills:
  • Strong project management, interpersonal, and communication skills, with the ability to represent AL Solutions in cross-company activities.
  • Broad knowledge of advanced statistical concepts and techniques, including Bayesian methodology.
  • Ability to adapt to changing circumstances, innovate, and continuously improve practices.
Language:
  • Fluency in German and English (both written and spoken).
Benefits:
  • Competitive salary
  • Annual Bonus
  • Car allowance or company car
  • Fantastic work-life balance

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