+ Ensuring that all statistical aspects of documentation pertaining to clinical programs and non-study activities meet required standards and are statistically correct.
+ Influencing study design, and defend statistical approaches internally and externally.
+ Influence and contribute to the development strategy undertaken in Japan and defend internally and externally.
+ Adherence to Amgen Policies, SOPs and other controlled documents
**Key Activities include**
+ Partnering and collaborating with GBS and global teams in planning for, and delivering, outputs needed for Japan.
+ Providing strategic inputs and being the key Japan GBS contact for regulatory queries and assist with interactions with Japanese regulatory agencies.
+ Contributing GBS localization efforts with AABP and GBS as needed.
+ Master degree in Statistics / Biostatistics or other subject with high statistical content, and 3 years of directly related statistics experience in pharmaceutical industries.
+ Designing, analyzing and reporting of Japanese clinical trials within pharmaceutical / biotechnology / public health setting in industry, academia.
+ Communication of statistical information (written and oral).
+ Experience of working with global team members.
+ Communication skills in English for business needs.
+ Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 1 or 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research.
+ Knowledge of life cycle drug development (pre-clinical development, clinical development, and post-marketing).
+ Statistical contributions to regulatory submissions in Japan.
+ Experience interacting with Japanese regulatory agencies, in particular PMDA.
+ Leadership of at least 1 study/project with minimal oversight
+ Knowledge of fundamentals of project planning.
If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.