【Janssen】 R&D Clinical Biostatistics Senior Specialist
Johnson & Johnson
Chiyoda, Japan
1 日前

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 :

Accountability :

  • Provide statistical expertise in clinical developmentprograms, development strategy, study design, data analysis and interpretationof results for clinical trials;
  • 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.

    DecisionMaking :

    Proposal statistical documents, timeliness and qualityand / or input to JCoT assigned with advice / support from CB group managers

    Influence :

    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.

    Interface :

    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

    REQUIREMENTS :

    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

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