※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
Responsible for providing credible results of clinical data analysis and contributing the whole reporting process including quality control. This position supports statistical programming and analyses aspects of business‐critical and/or regulatory commitments for compounds in at least one Therapeutic Area (TA).
- Provides the expertise in clinical data analyses to support clinical trials in at least one TA; develop statistical deliverables with high quality in timely manner; review and contribute to cross‐functional documents;
- Review the Protocol Element Documents (PED)/protocols.
- Contribute to the study set‐up activities (CRF design, database specification etc) with study team members.
- Develop statistical documents for analysis planning such as data presentation specification(DPS) and analysis dataset specifications in collaboration with Biostatistician.
- Develop statistical analysis programs by managing external programming resources and ensure providing credible deliverables in timely manner.
- Conduct statistical analyses in collaboration with Biostatistician, and deliver statistical results for Top Line Results documentations and CSR/ regulatory documents, with high quality in timely manner.
- Review the contents of CSR/regulatory documents from the view point to ensure persuasiveness and consistency of data presentation to the contents.
- Provide support of clinical data analyses for regulatory approvals in timely manner.
- Enhance "Sustainable Efficiency" for the whole data processing by using structured & systematic approach such as; implementation, development and management of clinical data standards, and strategic outsourcing.
- Make "up‐to‐date" technical solutions available by utilization of various technology and intelligence in statistical analysis & reporting
- Contribute to the implementation of continuous process improvements while maintain sustainable efficiency in globally consistent processes/systems, especially for processes relevant to data processing such as analysis standards and statistical computing environment in clinical development.
- Recommend timeliness and quality related to deliverables of statistical programming activities (e.g., development, verification and documentation), and/or input to team assigned as Clinical Informatics Lead, with advice/support from managers of CI group
- Provide statistical programming expertise to recommend timeliness and quality required to deliverables of statistical programming activities
- Implement "state‐of‐the‐art" statistical programming approach and technology as much as possible
- Contribute to the implementation of continuous process improvements while maintain sustainable efficiency
- Internal; JCoT, QS‐J Matrix team, managers in CI group, Group managers in Biostatistics dept, Statistical programmers including Data Analysis Leads in global IDAR for projects assigned, Statistical programmers in DDA China for projects assigned
- External; PMDA, Academia related to projects assigned, Professional Societies, CRO partners outsourced for projects assigned
- 6‐8 years' experience related to statistical programming field in a team environment, with increasing responsibility, preferably in a pharmaceutical/Clinical R&D environment.
- Good knowledge as drug developer, such as ICH guidelines, PMDA's guidelines, and basic preference of study design in TA of projects assigned.
- Good skill and knowledge for statistical programming & analyses for computing / programming with at least one statistical package software such as SAS, R, etc.
- Basic knowledge of project management
- Good written, oral, and interpersonal communication skills.
- Ability to work independently.
- Demonstrated ability to work in interdisciplinary contexts outside statistical programming field
- Bachelor's degree or higher and/or equivalent in computer science, mathematics or other scientific field (or equivalent theoretical/technical depth).
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.