Senior Manager Biostatistics

2 days ago

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

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

Key Responsibilities
  • Design and Implement Statistical Processes: Develop and implement rigorous, informative, and innovative statistical models and analysis methodologies to address research objectives.
  • Lead Clinical Trials: Design, implement, and report statistical processes in clinical trials, applying state-of-the-art concepts and tools to interpret clinical trial data.
  • Manage External Vendors: Oversee external vendors for outsourced activities and ensure deliverables meet project specifications, quality, budget, and timelines.
  • Contribute to Global Value and Access Deliverables: Author and contribute to Global Value and Access deliverables, such as Global Value Dossiers and Orphan Drug Designation submissions.
  • Provide Expert Statistical Advice: Offer statistical input for selection and evaluation of external vendors and ensure statistical deliverables meet project specifications.
  • Plan and Track Statistical Activities: Schedule and track statistical activities to ensure high-quality, timely, and accurate completion of statistical deliverables.
  • Manage Statistical Input to Reimbursement Review Process: Address payer questions in a timely, technically sound, and clearly presented manner.
  • Develop Statistical Processes: Work with other statistician colleagues to develop statistical processes within the Ipsen Group.
  • Stay Up-to-Date with Current Issues and Developments: Keep abreast of current issues and developments in statistical theory and application.
Requirements
  • Advanced Knowledge of Statistics and Drug Development Process: Apply advanced knowledge of statistics and the drug development process to clinical studies.
  • International Standards and Regulatory Submission Experience: Have a high understanding of international standards (ICH, GCP, CDISC) and regulatory submission experience (FDA, EMA, etc.).
  • Statistical Software Tools: Be proficient with statistical software tools such as SAS, R, S-Plus, EAST, JMPC, etc.
  • Strong Attention to Detail and Communication Skills: Possess strong attention to detail, excellent communication skills, good interpersonal skills, and cross-cultural understanding and sensitivity.
  • Ability to Manage Multiple Complex Projects: Be able to manage multiple complex projects and assess resource needs.
Education and Experience
  • MS/PhD in Statistics or Biostatistics: Hold a Master's or Ph.D. in statistics or biostatistics or a related field.
  • Experience in Clinical Research: Have experience as a statistician in clinical research, with a minimum of 7 years of experience.

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