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.
Purpose of the function
This position supports oncology development and leads complex studies in study design, statistical analysis and interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems.
Roles and Responsibilities
- Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR)
- Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review.
- Acts as main statistical contact for the assigned studies and projects.
- Provides guidance to study team on all aspects of statistical activities
- Collaborates closely with data manager to ensure high quality data.
- Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.
- CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies.
- Ensures deliverables are accurate and delivered according to the timelines.
- Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document.
- May participate in meeting or teleconferences with Health Authorities-
- Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
Education & Experience
- Extensive experience in the pharmaceutical industry with a masters degree required
- Profound knowledige in the pharmaceutical industry
- Master's Degree in statistics or biostatistics required with a PhD preferred
Skills and additional Requirements
- Proven experience in oncology clinical trials is a plus- Strong understanding of regulatory requirements (FDA, EMA, ICH guidelines)
- Extended and up-to-date knowledge of statistical methods for survival analysis
- Experience managing CROs and cross-functional project teams
- Experience with statistical software such as SAS and R.
