Senior Manager Biostatistics HF

3 weeks ago

London, Greater London, United Kingdom Lifelancer Full time
About the Role

We are seeking a highly skilled Senior Manager Biostatistics HF to join our team at Lifelancer. As a key member of our Global Biometry team, you will play a critical role in supporting the development of Health Technology Assessments (HTA) in collaboration with our Health Economics and Outcomes Research (HEOR) and Global Value and Access teams.

Main Responsibilities
  • Design and implement rigorous statistical models and analysis methodologies to address research objectives.
  • Conduct exploratory statistical analyses of clinical trial data to support HTA objectives.
  • Contribute to the authoring of Global Value and Access deliverables, including Global Value Dossiers and Orphan Drug Designation submissions.
  • Provide expert statistical advice to address questions from local country authorities in the reimbursement review process.
  • Manage the statistical input to the reimbursement review process, addressing payer questions in a timely, technically sound, and clearly presented manner.
  • Develop statistical processes within the Ipsen Group by working with other statistician colleagues.
  • Stay up-to-date with current issues and developments in statistical theory and application, and advise on the implementation of new statistical developments.
  • Maintain a good network of contacts with outside bodies relevant to clinical statistics.
Requirements
  • Advanced knowledge of Statistics and the drug development process applied to clinical studies.
  • Advanced understanding of statistical methods used in evidence synthesis to clinical trial data.
  • High knowledge of international standards (ICH GCP CDISC) and regulatory submission experience.
  • Proficiency with statistical software tools such as SAS R SPlus EAST JMPC.
  • Strong attention to detail, excellent communication skills, good interpersonal skills, and cross-cultural understanding and sensitivity.
  • Ability to see the big picture while keeping an eye on details.
  • Independent problem-solving and self-direction skills.
  • Ability to manage multiple complex projects and assess resource needs.
Education and Experience
  • MS/PhD in Statistics or Biostatistics or related field.
  • Ideal: PhD with 4 years of experience in a similar position. Good experience of participating in selection and management of external vendors.
  • Minimum: MS with 7 years of experience as statistician in clinical research.

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