Director of Biostatistics and Data Science

5 days ago

Leeds, Leeds, United Kingdom Warman O'Brien Full time
Job Description

**Job Title:** Director of Biostatistics and Data Science

**Job Summary:** We are seeking a highly skilled Director of Biostatistics and Data Science to join our team at Warman O'Brien. As a key member of our organization, you will be responsible for providing statistical expertise and leadership to support the development of pharmaceutical products.

Key Responsibilities:

  • Provide statistical expertise and contributions for projects and protocols in support of Drug Development Programs
  • Lead the development of statistical methodologies and ensure quality and appropriateness of submission deliverables
  • Oversee statistical support to planning, preparation, review, and interpretation of data for clinical trials (interventional, observational and registries studies)
  • Ensure that data are analysed and evaluated with appropriate statistical methodologies
  • Coordinate Statistical Input for all clinical and safety data systems at Warman O'Brien and support preparing data and metadata packages for regulatory submission
  • Lead operational activities of staff members

Requirements:

  • A significant experience in the field, as defined below, is required for the current role:
  • (MANDATORY) At least 10 years of experience in the role of statistician in the clinical development of pharmaceutical products in pharmaceutical industries and/ or CROs (possibly including phase 4 and registry/observational studies)
  • (HIGHLY VALUED) Experience in clinical trials for rare diseases and of study design and statistical analysis approaches typically used in small population trials
  • Experience in interactions with Regulatory Agencies, researchers, health care
  • A clear experience and mastering of the following standards should also be demonstrated:
  • ICH GCP as well as general knowledge of industry best practices and standards, such as CDISC (ADaM)

Education:

  • University Degree in Statistics, Mathematics or related disciplines

Languages:

  • English Fluent

Soft Skills:

  • Attention to details
  • Communication skills
  • Leadership and social influence
  • Planning and organizational skills
  • Strategic thinking

What We Offer:

  • A dynamic and collaborative work environment
  • Opportunities for professional growth and development
  • A competitive salary and benefits package

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