Jobs for People with MS: National MS Society

Responsible for

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 analysis, and defending statistical approaches internally and externally.

Influencing and contributing to the development strategy undertaken in Japan

Adhering to Amgen Policies, SOPs and other controlled documents.

Key Activities include

Partnering and collaborating with Global Biostatistical Science (GBS) and global teams in planning for, and delivering, outputs needed for Japan.

Providing strategic inputs and being the key Japan Biostatistics contact for regulatory queries and assist with interactions with Japanese regulatory agencies.

Contributing GBS localization efforts with Amgen K.K. and GBS as needed.

Basic Qualifications

• Master degree in Statistics / Biostatistics or other subject with high statistical content, and 6 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.

Preferred Qualifications

• 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/interactions 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.