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Senior Biostatistics Director

1 month ago


London, Greater London, United Kingdom Warman O'Brien Full time
Associate Director Biostatistics

We are seeking an experienced Associate Director Biostatistics to join our dynamic team at Warman O'Brien. As a key member of our Biometrics department, you will play a crucial role in providing statistical expertise and support for our clinical trials and regulatory submissions.

Key Responsibilities:
  • Provide statistical input for study design, sample size calculation, and data analysis
  • Ensure compliance with regulatory requirements and industry best practices
  • Collaborate with cross-functional teams to develop and implement statistical methodologies
  • Supervise and support statistical staff to ensure high-quality deliverables
  • Interact with regulatory agencies and CROs to address queries and provide statistical support
Requirements:
  • At least 10 years of experience in biostatistics, with a strong background in clinical trials and regulatory submissions
  • Experience in interactions with regulatory agencies, researchers, and healthcare professionals
  • Strong knowledge of ICH GCP and industry best practices, such as CDISC (ADaM)
  • University degree in Statistics, Mathematics, or related disciplines
  • Fluent English language skills
What We Offer:
  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A competitive salary and benefits package