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Clinical Development Director

3 weeks ago

Copenhagen, Copenhagen, Denmark IQVIA Argentina Full time

About the Role

Key Responsibilities

The Principal Biostatistician will be responsible for leading components of statistical contribution to a clinical development program, including developing and executing statistical strategies for study design and data analysis. Key responsibilities include:

  • Developing and executing statistical strategies for study design and data analysis in clinical trials and regulatory submissions.
  • Collaborating with cross-functional teams to develop study protocols, data collection plans, and statistical analysis plans.
  • Authoring initial statistical analysis plans for clinical trials and regulatory submissions.
  • Supporting interactions with regulatory authorities.

Required Skills and Qualifications:

  • PhD with 5 years of experience or MS with 8 years of experience in drug development.
  • Experience providing statistical leadership at a study level.
  • Strong experience in Phase II, III & IV.

Benefits:

  • A competitive salary and benefits package.
  • Ongoing training and professional development opportunities.
  • A collaborative and dynamic work environment.