Astellas Pharma Inc. is looking to develop innovative therapies for patients, and this Statistical Scientist Lead role is expected to provide statistical solutions on clinical trial design and analysis, enabling innovation in statistical methodology, and researching solutions for novel situations in oncology.
Requirements
- PhD (or MSc with equivalent experience) in Biostatistics, Statistics, or a related quantitative discipline
- Excellence in modern statistical methods in clinical trials, including advanced Bayesian methods, adaptive designs, external control arms, seamless designs, efficacy and safety monitoring, and quantitative decision-making (especially in oncology)
- Strong scientific contributions through publications (at least 5 papers), presentations, and participation in industry/regulatory working groups
- Excellence in statistical software (e.g., SAS, R) and familiarity with simulation tools
- Familiarity with AI/ML applications in clinical development
- Experience working with real-world data sources, including data integration, study design, and interpretation
- Broad expertise across clinical trial statistics, exploratory statistics, Medical Affairs statistics, biomarker statistics, safety/PV statistics, real-world evidence (RWE) analytics, and statistical programming
Responsibilities
- Provide statistical solutions on statistical designs, statistical analyses, simulation works, and other methodological activities for Phase 1 through Phase 4 studies across multiple therapeutic areas
- Have expertise in statistical methodology in early-stage designs, including dose optimization, efficacy and safety monitoring, basket trial design, and quantitative decision-making in oncology
- Ensure the implementation of statistical and methodological activities in all drug developments and clinical trials
- Provide the QC of sample size calculation, quantitative decision making (QDM), highly statistical analysis, and simulation work for whole drug developments and clinical trials
- Proceed with multiple research projects, providing impacts in the research area and leading the research area as an industry expert
- Develop a reliable network of academics, regulatory experts, and industry peers and investigate and share new statistical methodologies
- Mentor statisticians and analytics professionals across QSEG, supporting scientific development
Other
- Minimum of 5 years of industry and/or academic experience in clinical development with increasing responsibility and strategic impact
- Strong communication, collaboration, and stakeholder engagement skills across both technical and non-technical audiences
- Travel may be required
- Must be eligible to work in the United States
- EOE including Disability/Protected Veterans
