Aktuelle Jobs im Zusammenhang mit Safety Expert - Frankfurt am Main, Hessen - AL Solutions


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Safety Expert

vor 2 Monaten


Frankfurt am Main, Hessen, Deutschland AL Solutions Vollzeit

AL Solutions is seeking a highly experienced Safety Expert Statistician to join our team in Germany. As a key member of our safety team, you will play a critical role in leading safety signal detection, validation, characterization, and reporting for multiple projects.

This is an exciting opportunity to join a leading international organization that specializes in multiple areas and has an experienced and knowledgeable team to support you in your career.

This role offers a fantastic opportunity to have a perfect work-life balance and be part of a dynamic team that is passionate about delivering high-quality results.

Main Responsibilities:

  • Lead safety signal detection, validation, characterization, and reporting for multiple projects with minimal direction from the group head.
  • Provide direct statistical support and scientific leadership for clinical trial safety data within a project.
  • Plan and track project activities related to safety, including timelines and resource use, while promoting teamwork.
  • Lead discussions on defining and harmonizing quality standards at both the individual trial level and across therapeutic areas.
  • Provide technical guidance and mentoring to junior staff.
  • Ensure productive collaboration with other functions in the safety monitoring team and with other statistics project leaders, as well as effective communication with senior leadership.
  • Represent statistics in scientific or technology working groups or cross-functional initiatives, leading when applicable.

Requirements:

Education and Professional Experience:

  • PhD/MS in statistics or a related discipline.
  • Broad experience in clinical development or post-marketing activities such as submissions, interactions with regulatory agencies, or other external stakeholders. Experience in safety signal detection is desired.

Soft Skills:

  • Demonstrated strong project/study management, interpersonal, and communication skills.
  • Broad knowledge and good understanding of advanced statistical concepts and techniques, including Bayesian methodology.
  • Ability to represent AL Solutions in cross-company activities such as consortiums or professional associations.
  • Ability and mindset to embrace change, innovate, and continuously improve practices.

Languages:

  • Fluency in German and English (both written and spoken).

Benefits:

  • Car allowance or company car
  • Annual Bonus
  • Fantastic work-life balance
  • Competitive salary