16861 Senior Principal Biostatistician
Your responsibilities include, but not limited to:
・Work independently at the clinical trial level and lead project level statistical activities for oncology development project under very limited supervision.
・Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned project.
・Responsible for all statistical tasks on assigned PMS, including development of protocol and statistical analysis plan, and reporting activities in collaboration with preferred vendors.
・Propose and lead implementation of modern and innovative trial/experimental designs, statistical models, analyses and data exploration methodologies at the study or project level.
・Mentor new hires and/or junior statisticians.
What you’ll bring to the role:
・Be statistical representative immediately for multiple projects in Oncology area regardless of clinical phase including post-approval commitment such as post-marketing surveillance (PMS) and re-examination application.
・Proactive contribution to non-drug projects such as cross-functional or biostatistics line function initiative, focusing on the operational and/or scientific excellence.
・Work locally and globally, by taking trial statistician role for multi-regional trial.
・Seek new business opportunity which increases our core value as statistician or data scientist.
・Highly inspired by external engagement leading to the company’s reputation in statistical field, e.g., presentation at a statistical conference or contribution to a JPMA taskforce or DIA Japan etc.
・MS (in Statistic or equivalent) with 7+ years relevant work experience or PhD (in Statistic or
equivalent) with 3+ years relevant work experience.
・Good communication and presentation skills.