Job Details

Senior Director of Biostatistics

  • £Competitive
  • , United Kingdom
  • Permanent
Senior Director, Biostatistics - UK/Remote 

Provide leadership with a focus on full management support in all aspects of internal projects and projects with external clients. This position is accountable for coaching, mentoring, developing, providing technical review, advise, and expertise to Biostatisticians, Statistical Programmers, and data management professionals. These activities include developing divisional goals and objectives; developing, implementing, and enforcing policies, procedures and standards; ensuring high quality standards and ensuring smooth divisional operation. Providing expert professional assistance and fostering cooperative working relationships internally and with external clients as required.

In addition, this position provides close oversight of the statistical and data management team activities for clinical trials from the development of study protocols to the completion of study reports.


  1. Provides leadership/expertise in resolving complex problems in support of divisional/company objectives and projects, or as resource to others. May represent division or company - provide leadership in major divisional/corporate efforts and in executing divisional or corporate plans. These efforts may include, but are not limited to, the following:
    1. Providing leadership/expertise in day-to-day statistical operations within the division and in research and development of statistical methodologies in solving practical statistical problems.
    2. Participating in new business development and bidding processes.
  2. Promote a culture of high-quality standards, on-time delivery within budget for all stages of the clinical trials – from the trial design, protocol development, statistical analysis planning and execution, to the writing of statistical sections of Clinical Study Reports (CSRs) or the generation of publications of trial results.
  3. Serve on the management team at the corporate level ensuring divisional needs and concerns are represented.
  4. Provide technical oversights to the biostatisticians (i.e. provide consultation to biostatisticians and review their statistical products when required).
  5. Provide high expertise in statistical methods and techniques in support of ongoing statistical projects and clients. Perform review for clinical study protocols, Statistical Analysis Plans, CSRs, and other important trial documents to ensure quality of statistical deliverables when necessary. Provide face to face statistical consultation to trial medical/clinical personnel when required.
  6. Provide supervision to ongoing projects by applying management skills, regulatory standards and requirements, and quality management to ensure quality and timely deliverables. Direct staff teams on performing complex statistical analyses or resolving difficult problems. Maintain expertise in state‑of-the-art statistical methodology and regulatory requirements.
  7. Monitor and assess the progress status of ongoing projects. Make recommendations for improvement and ensure organizational effectiveness and efficiency.
  8. Serve as the primary contact between divisional areas and to clients for responsible areas. Manage Sponsors and vendor relationship. Participate in regular and ad hoc management meetings with clients. Proactively prevent Sponsor/vendor relationship issues, and closely follow up on the resolution of existing issues.
  9. Develop divisional statistical and data management performance requirements and measurements according to the corporate standards. Perform ongoing assessment/measurement of project team performance against set standards.
  10. Perform semi-annual and annual performance reviews for direct subordinates and, where appropriate, indirect subordinates. Plan and carry out the developmental plans for existing and new staff.
  11. Contribute to organization development and growth by actively recruiting and staffing for the responsible functions, and coaching, mentoring, and developing staff members.

  1. A Ph.D. in Biostatistics or Mathematics with over 10 years of experience in clinical research and development, as well as a minimum of 6 years of line management experience.
  2. Strong pharmaceutical industry statistical experience and broad knowledge of clinical research and development.
  3. Clinical Trial experience: Managing and working knowledge of all statistical and data management aspects of clinical trials (Phase I to IV).
  4. Experience with client relationship management and developing future business.
  5. Experience and previous practice in SAS programming.
  6. Strong ability in statistical operational management.
  7. Knowledge of all clinical trial tasks from protocol design to final study reporting.
  8. Knowledge of clinical, statistical and data management related regulatory guidance documents, FDA/ICH guidelines and applicable federal regulations.

Interested? Drop me a message or send your CV to receive more details surrounding this role and discuss this further!
Shane Hanney Consultant in Biostatistics

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