Principal Biostatistician

6 days ago

London, Greater London, United Kingdom Warman O'Brien Full time
Job Summary

We are seeking a highly skilled Senior Biostatistician to join our team at Warman O'Brien. As a key member of our Statistical Operations management team, you will be responsible for managing clinical trial programs and projects from one or multiple clients.

Key Responsibilities
  • Program Management: Collaborate with the Statistical Operations management team to oversee clinical trial programs and projects, ensuring timely and efficient delivery.
  • Statistical Oversight: Provide statistical input on projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, and data handling.
  • Team Leadership: Coach, mentor, and develop less experienced Biostatisticians and Statistical Programmers, providing technical review, advice, and expertise.
  • Protocol Design: Participate in the writing of trial protocols and research proposals, ensuring statistical input is incorporated.
  • Data Management: Review and provide input to clinical data management deliverables, including eCRFs, eCRF Completion Instructions, data validation specifications, and Data Management Plan.
  • Statistical Analysis: Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports, performing peer review of SAPs and other technical documents.
  • Quality Control: Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians.
  • Regulatory Compliance: Ensure all study-level and drug-program-level statistical and programming activities are conducted in compliance with relevant regulatory requirements.
  • Collaboration: Interact with regulatory agencies and support sponsors in new drug application, contributing to organization development and growth.
Requirements
  • A Ph.D. degree in statistical science, mathematical analysis, or related fields.
  • OR A Master's degree in the above fields.

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