JOB SUMMARY :
Responsiblefor providing statistical expertise in clinical development programs, compoundlevel development strategy, study design, data analysis and interpretation ofresults for clinical trials, as well as regulatory filings and approvals as abiostatistician responsible for compound level (i.
e., JCoT). This positionsupports statistical aspects of business critical and / or regulatorycommitments.
KEY RESPONSIBILITIES :
Contribute to develop clinical development programs,development strategy and study design, in terms of statistical viewpoint.
Develop the Protocol Element Documents (PED) / protocolswith protocol writers, in terms of statistical viewpoint, and contribute to thestudy set up activities (randomization, and IXRS specification etc.
with studyteam members.
Develop statistical documents for analysis planning suchas statistical analysis plan (SAP), data presentation specification(DPS) incollaboration with Clinical Informatics Lead.
Contribute to conduct statistical analyses (with ClinicalInformatics Lead) and deliver statistical results for CSR / regulatory documentsin timely manner.
Create topline results documents.
Provide statistical interpretation of study results, andreview the contents of CSR / regulatory documents.
Proposal statistical documents, timeliness and qualityand / or input to JCoT assigned with advice / support from CB group managers
Facilitate strategic & data oriented (quantitative)discussion by utilizing statistical thinking such as modeling & simulationapproach
Provide statistical expertise to developpersuasive / logical data interpretation for regulatory approvals in timelymanner.
Implement state of the art statistical strategies andadvanced methodology
Contribute to the implementation of continuous processimprovements while maintain sustainable efficiency in globally consistentprocesses, such as data standards and process standardization.
Internal; JCoT, QS J Matrix team, Group managers inBiostatistics dept, Statisticians including CTSL in SDS of global QS forprojects assigned, Statisticians in SDS China for projects assigned
External; PMDA, Academia related to projects assigned,Professional Societies, CRO partners outsourced for projects assigned
Spanof Control :
Budget : planning & execution for projects assigned
Headcount : not applicable
Experience / Knowledge
Good knowledge as drug developer, such as ICH guidelines,PMDA’s guidelines and basic preference of study design in TA of projectsassigned.
Skills / Capabilities
Good skill and knowledge for statistical analysis,reporting and simulation not only got methodology but also forcomputing / programming with R, SAS and / or another statistical package software.
Good written, oral, and interpersonal communicationskills.
Ability to work independently.
Demonstrated ability to work in interdisciplinarycontexts outside statistics.
Qualification / Certificate
Master degree in Statistical sciences, or equivalent.
Generally, requires (6 8) years related experience
REPORTING RELATIONSHIPS :
Groupmanager, Clinical Biostatistics, Biostatistics department, Quantitative ScienceDivision, Japan R&D