業務内容：

• ・The position is responsible for providing support to Japan clinical development projects statistical sciences/programming. This support is supplied in the context of a cooperative, project-oriented effort and included data capabilities in general planning and execution of clinical trials, statistical analysis and reporting of the data from these trials, and regulatory submissions and inspections.
• ・Perform statistical analysis as per the analysis plan. Collaborate with Statistical Sciences/Programming to ensure the delivery of high-quality outputs according to agreed-upon timelines.
• ・Develop strategy for data presentation and inference. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
• ・Identify scientifically appropriate data collection instruments. Identify and report data issues or violations of study assumptions. Partner with Data Science in preparing for database lock.
• ・Responsible for the creation and accuracy of derivation programs, including peer review.
• ・Responsible for the creation and accuracy of submission data sets and analysis programs. Responsible for the creation of data definition documents.
• ・Support for dealing with the authorities. Perform follow-up and analysis of clinical study data, based on requirements and comments from PMDA, and support preparation of response.

要件：

• ・At least 5 years of experience in pharmaceutical R&D including at least 3 years’ experience in Data management and Statistical Sciences/Programming areas.
• ・A bachelor’s degree in or equivalent knowledge of statistics/mathematics, pharmacy, biology, pharmacology or related scientific field focused on quantitative skills. A master’s or doctor’s degree is more favorable.
• ・Proficient in English communication skills (TOEIC 650 or more or equivalent)

歓迎：

• ・CDISC and e-data submission
• ・Unix-SAS
• ・Statistics for clinical development
• ・Work with global

勤務地：東京