Senior Director Biostatistics Process Excellence

Senior Director- Biostatistics, Process Excellence

** REMOTE WORKING OPPORTUNITIES AVAILABLE ACROSS GERMANY AND UNITED KINGDOM **

The Senior Director of Biostatistics, Process Excellence will lead the biostatistics function within a clinical development organization. This role is pivotal in ensuring that statistical methodologies and processes are optimized to support the design, analysis, and reporting of clinical trials. The successful candidate will work closely with cross-functional teams to enhance operational efficiency, drive innovation in statistical practices, and ensure compliance with regulatory standards.

Main Responsibilities

• Lead initiative for continuous improvement for oncology profile and drive biostatistics strategy in accordance with company objectives.
• Provide leadership and mentorship to a team of biostatisticians, fostering a culture of excellence and continuous improvement.
• Develop and enhance biostatistics processes related to clinical trials.
• Work closely with clinical operations, data management, regulatory affairs, and other departments to ensure seamless integration of biostatistical activities into clinical trial processes.
• Ensure all biostatistical activities comply with relevant regulations (e.g., FDA guidelines) and industry standards.
• Identify process improvement and communicate with stakeholders to ensure alignment with strategic strategies
• opportunities, and cooperate with stakeholders to scope and ensure alignment with strategic
  priorities
• Assess and evaluate the quality measure analysis, taking into account performance enhancement and reporting, offering suggestions to the GBS (Global Business Service) leadership team. 

Profile

• Scientific or Mathematic degree
• Extensive background within pharmaceutical industry
• Strong background leading cross-functional teams 
• Strong understanding of drug development process
• Demonstrated experience in project management

Benefits

• Competitive salary, bonus and attractive packages 
• Remote working 
• Excellent company culture
• Professional career growth opportunities 
• Exposure to a dynamic and evolving Biotech company