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.
年収：年俸制、昇給年1回 （採用ポジションにより年収パターンあり） 賞与：年3回（管理職は年1回）
【必須（MUST）】・A bachelor’s degree in or equivalent knowledge of statistics/mathematics, pharmacy, biology, pharmacology or related scientific field focused on quantitative skills.
・At least 5 years of experience in pharmaceutical R＆D including at least 3 years’ experience in Data management and Statistical Sciences/Programming areas.
・Proficient in English communication skills （TOEIC 650 or more or equivalent）
【歓迎（WANT）】・A master’s or doctor’s degree is more favorable.
・The following experiences and knowledges are preferred.
－CDISC and e－data submission
－Statistics for clinical development
－Work with global
・Good leadership skills as defined by our core leadership behaviors.