Business Services & Consulting • all cities, PA 39
Senior Director Biostatistics Process Excellence (39)
all cities, PA 39On-sitePosted 22 hours ago
Business Services & Consulting
About the Role
Senior Director Biostatistics Process Excellence
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
Senior Director Biostatistics Process Excellence
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
What You'll Do
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
