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Statistical Leader in Rare Disease Clinical Trials
2 months ago
We are seeking a highly skilled Associate Director Biostatistics to lead our team in the development of innovative statistical solutions for rare disease clinical trials. As a key member of our biometrics department, you will be responsible for providing expert statistical guidance and support to ensure the success of our projects.
Job SummaryThe successful candidate will have a strong background in biostatistics, with at least 10 years of experience in the pharmaceutical industry or CROs. They will be responsible for leading statistical input for all clinical and safety data systems, ensuring compliance with regulatory requirements, and managing the operational activities of staff members.
Main Responsibilities- Provide statistical expertise and contributions for projects and protocols in support of Drug Development Programs
- Ensure that data are analysed and evaluated with appropriate statistical methodologies
- Coordinate Statistical Input for all clinical and safety data systems at Chiesi and support preparing data and metadata packages for regulatory submission
- Coordinate operational activities of staff members
- Work with the other functions in assessing and leveraging the need for statistical input
- A significant experience in the field, as defined below, is required for the current role:
- (MANDATORY) At least 10 years of experience in the role of statistician in the clinical development of pharmaceutical products in pharmaceutical industries and/ or CROs (possibly including phase 4 and registry/observational studies)
- (HIGHLY VALUED) Experience in clinical trials for rare diseases and of study design and statistical analysis approaches typically used in small population trials
- Experience in interactions with Regulatory Agencies, researchers, health care
- University Degree in Statistics, Mathematics or related disciplines
- English Fluent
- Attention to details
- Communication skills
- Leadership and social influence
- Planning and organizational skills
- Strategic thinking
Salary: £80,000 - £110,000 per annum, depending on experience.