The Director of Biostatistics mission will be to help shape the evidence generation strategy across Clinical Development. This role will be responsible for developing study protocols and statistical analysis plans, delivering statistical analyses and reports and supporting regulatory dossiers and meetings, scientific presentations, and publications Independently leads quantitative strategy. Represents Biostatistics at internal and external meetings, health authority interactions; Lead Biometrics and provide strategic, technical, operational and scientific leadership and solutions to the organization.
Your responsibilities will include:
- Leads the study and project level for all statistical tasks including protocol development, statistical analysis plan and reporting activities; planning and execution of exploratory analyses; innovative analyses related to publications and pricing & reimbursement submission analyses.
- Supports clinical and regulatory function in interactions with external stakeholders and internal decision boards
- Represents statistical discussions at conferences, scientific meetings.
- Be the got to for all statistical concepts in an easily understandable way to non-statisticians
- Manages deliverables and ensure timeliness and adequate quality.
- Provides statistical consultation on trial design and study endpoints, calculates sample sizes and authors statistical analysis plans, utilizes knowledge of Regulatory requirements and guidance documents to provide statistical advice with respect to creating a clinical development program
- Over 10 years relevant work experience or PhD (in Statistics or equivalent)
- A minimum of 5 years of drug development industry experience
- Ability to lead analysis, data visualization and reporting of clinical trial in drug development
- Experience in implementation of innovative statistics and quantitative analytics to influence studies, projects and development strategies.
- Lead a multidisciplinary Biometrics clinical trial team.