At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary
Position leads multiple early phase compounds or complex studies contributing to clinical development plan, and responsible for statistical design, analysis and interpretation of results independently with minimal supervision. This position provides strategic inputs to entire drug development plans with minimal supervision and regulatory responses and other documents with minimal supervision. This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works under minimal supervision to solve complex project problems. This position utilizes innovative trial designs and modeling to optimize the statistical handling in the projects, in collaboration with statistical innovation group, precision medicine biostat group, and real-world data (RWD) group. This position collaborates with cross functional project leaders from translational medicine, clinical operation, CSPV, clinical development and other functions in GPTs
Responsibilities
Act as statistical expert in the assigned projects. Guides the project team in using the most efficient or innovative study design by considering the regulatory agencies’ requirements for the country and Regions the compound will be submitted, and helps to maximize the success of the drug product. May also serve as a lead statistician for certain studies and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions the drugs will be submitted. Ensures consistency in -derived data definition, - statistical analysis and result interpretation; Leads the planning and analysis of integrated efficacy and safety data.
Mentoring and Coaching Junior Statisticians: Mentoring the study level statisticians for the assigned projects to ensure optimal statistical handling and quality deliverables including Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR).
CRO / Vendor Interaction: Participates in reviewing the proposal for CRO selection. Reviews and negotiates - timelines; Guides CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, - analysis methodologies, and interpretation of analysis results. Ensures timely delivery of high quality deliverables.
Qualifications
Education
PhD in statistics or biostatistics required
Work Experience
7+ years of relevant experience in the pharmaceutical industry required
Competencies
Travel Requirements
Ability to travel up to 20%
International travel may be required
Why work with us?
Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.