This company is the world's leading biopharmaceutical company and are committed to applying science and their global resources to improve health and well-being at every stage of life. They strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them. They have a leading portfolio of products and medicines that support wellness and prevention, as well as treatment and cures for diseases across a broad range of therapeutic areas including an industry-leading pipeline of promising new products that have the potential to challenge some of the most feared diseases of our time, like Alzheimer's disease and cancer.
1. Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and commercialization projects.
2. Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports (topline reports, clinical study reports, etc.), including clinical trial/PMS results, support for publication activities, scientific presentations, and support to responses to queries from regulatory authority.
3. Be accountable for study/PMS level and submission level statistical deliverables on assigned projects.
4. Develop effective collaborations with others within clinical teams, partner lines (such as, PharmSci, SRM, Regulatory Affairs), and external regulatory, industry, professional and academic organizations.
5. Ensure that all study/PMS and project level statistical activities are conducted in compliance with relevant regulatory requirements and company standards.
6. Be up-to-date on SOP training and compliance with all company SOPs as required based on the assigned curriculum.
7. Provide statistical input and leadership to cross-functional activities – collaborate with other statisticians, study managers, Clinical Programming colleagues – for assigned studies/PMS and regulatory submissions.
8. Ensure timeliness and quality of statistical deliverables according to project plans for assigned projects.
9. Comply with all statistics and quality processes and company data standards that are applicable to statistical outputs, and support processes that require statistical input.
10. Communicate and collaborate with global BU/RU statisticians on assigned projects.
11. Provide a strong statistical presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice.
12. Participate in research on statistical methodology and its applications to clinical trials/PMS.
Our client is leading life science company with a strong Japan business.