Data-Driven Clinical Research Lead

3 days ago

erode, India beBeeStatistical Full time

Seeking an experienced Statistical Programmer to work with our global pharmaceutical clients. As a Principal Statistical Programmer, you will be dedicated to one of our esteemed partners, driving next-generation patient treatment and empowering individuals with autonomy.Job Overview:This position reports directly to the Director of Biostatistics and Programming within our organization's FSP Services unit. The Principal Statistical Programmer works independently with concept-level instruction and minimal supervision, tracking progress and providing technical support to team members.Key ResponsibilitiesDevelop SDTM, ADaM specifications, datasets, reviewer’s guide, and define.xml files for multiple clinical studiesCreate SAS programs generating datasets, complex listings, tables (including descriptive and standard inferential statistics), and graphsDeliver high-quality statistical programming results, developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needsParticipate in overseeing CRO's statistical programming deliverables for multiple clinical studies, ensuring quality and meeting timelinesSupport study report preparation, regulatory submissions, publications, annual DSUR, and exploratory analysesUnderstand and follow FDA regulations affecting clinical trial data reporting, including good clinical practice and guidelines for electronic submissionsContribute to creating, maintaining, documenting, and validating programming tools, outputs, and macrosParticipate in CRF, edit check specification, and data validation plan developmentProvide review and/or author data transfer specifications for external vendor dataCollaborate with internal and external functions to ensure project timelines and goals are met

  • Leading Clinical Programmer

    3 days ago

    erode, India beBeeStatistical Full time

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    erode, India beBeeInternalAuditManager Full time

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    Erode, India iO Associates Full time

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    erode, India beBeeOpinion Full time

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  • Clinical Trials Compliance Specialist

    1 day ago

    erode, India beBeeCompliance Full time

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  • Clinical Site Compliance Specialist

    3 days ago

    erode, India beBeeCompliance Full time

    Compliance Specialist Job DescriptionAs a Clinical Site Compliance Specialist, you will be responsible for ensuring adherence to protocols, GCP, GLP, and regulatory requirements at clinical trial sites.Conducting site audits to verify compliance with regulations.Reviewing CRFs, informed consent forms, and regulatory documents.Identifying and reporting audit...

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    1 day ago

    erode, India beBeeDataLeader Full time

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    Erode, India LiveAltlife Full time

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    erode, India beBeeData Full time

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    erode, India beBeeData Full time

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