YOUR TASKS AND RESPONSIBILITIES
■Mainly set up statistical analysis programs for studies and integrated data and possibly perform set-up of EDC(Electronic Data Capture) system, Clinical Information Environment framework, mapping programs and JReview for studies etc.
■Contribute to IDRP (Integrated Data Review Plan) , SAP (Statistical Analysis Plan), study TLF (Tables, Listings and Figures) and ADS (Analysis Data Set) specifications.
■Provide EDC, statistical programming and validation support for all clinical study programming requests and the submission data/program package and for health authority questions in close collaboration with relevant functions.
■Contribute to delivery of study specific metadata structure definition, study specific mappings, programs and data deliverables (including data cut support) to support operational and analysis needs (e.g., SDTM and ADaM based on CDISC, Bayer ADS, etc.) in close collaboration with relevant functions.
■Support externally ran studies in conjunction with relevant functions.
■Create Data Review packages as required by study team.
■Ensure consistency within study standards and definitions by close collaboration with other relevant functions.
WHO YOU ARE
■Bachelor’s Degree or above
■At least 5 years of SAS programming experience in Statistics and/or Data Management in the pharmaceutical or biotechnology industry.
■Other programming skills like R, Python, PL/SQL, VBA or C# etc. are preferred.
■Business English TOEIC 600 or more
■Japanese level (N2 or above) or native Japanese level
■Strong Statistical Knowledge
・Building strong customer relationships and delivering customer - centric solutions.
・Building partnerships and working collaboratively with others to meet shared objectives.
・Planning and prioritizing work to meet commitments aligned with organizational goals.
HOW TO APPLY
Please apply for the position through our recruiting website with Japanese resume, Japanese working experience and English CV.
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