[R&D] Statistician, バイオメトリクス・データマネジメント統括部 統計担当者
Core
Design, analyze, and interpret clinical trials and post-marketing surveillance (PMS) to support drug development and regulatory submissions.
Role type
Senior biostatistician (clinical trials & PMS)
Builds
Clinical study reports, statistical analysis plans, regulatory submissions, and scientific publications.
Domain
Pharmaceutical industry, clinical drug development, regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Advanced statistical/epidemiological skills, clinical trial design expertise, regulatory guideline interpretation, cross-functional leadership, SOP compliance, research methodology
Preferred skills
Drug development lifecycle knowledge, clinical medicine understanding, academic collaboration
Technologies
SAS, R, Python, SQL, CDISC standards, EDC systems
Responsibilities
Develop statistical analysis plans and interpret results for clinical trials and PMS; author clinical study reports and regulatory submissions; collaborate with clinical pharmacologists and data managers; ensure compliance with regulatory requirements and company SOPs; influence regulatory guidelines through statistical expertise.
Seniority
Senior, hands-on IC with strategic input
