Responsible for providing statistical expertise in PMS programs, study design, data analysis and interpretation of results for PMS studies.
Provide statistical support for life-cycle management of launched products.
Provide statistical support in PMS programs / study design.
Develop study protocols with protocol writers and contribute to the study set up activities (CRF design, database specification etc.
with study team members.
Develop statistical documents for analysis planning such as SAP (statistical analysis plan) and other documents.
Monitor the analysis operations conducted by external service suppliers, an oversees design and implement quality control measures to ensure the quality and integrity of statistical results.
Deliver statistical results for periodical safety report / PMS regulatory documents in timely manner.
Provide statistical interpretation of study results and review the contents of PMS regulatory documents.
Provide statistical support for regulatory clearance in timely manner.
Contribute to the implementation of continuous process improvements while maintain globally consistent processes.
Provide consultancy for statistical questions from medical affairs / business units or external customers.
Enhance Sustainable Efficiency for the whole data processing by using structured & systematic approach such as; implementation, development and management of standardization and strategic outsourcing.
Decision Making :
Proposal statistical documents, timeliness and quality and / or input to team assigned as post marketing biostatistician, with advice / support from managers of CI group and Biostatistics dept.
Provide statistical expertise to recommend timeliness and quality required to deliverables of statistical activities
Implement state of the art statistical approach and technology as much as possible
Contribute to the implementation of continuous process improvements while maintain sustainable efficiency in globally consistent processes, such as data standards and process standardization.
Internal; JCoT, Post Marketing Data Management (PMDM), Safety Risk Management Dept (SRMD) managers in CI group, managers in Biostatistics dept.
External; PMDA, Academia related to projects assigned, Professional Societies, CRO partners outsourced for projects assigned
Experience / Knowledge
Generally, requires (6 8) years related experience
Basic knowledge of drug developer, such as ICH guidelines, PMDA’s guidelines, and basic preference of study design in TA of projects assigned
Skills / Capabilities
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 field.
Qualification / Certificate
Master degree in Statistical sciences, or equivalent