Principal Statistical Programmer FSP
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AI Summary AI Analysis
This role is for a Principal Statistical Programmer embedded within a pharmaceutical client to drive innovation in patient treatment. Key requirements include generating SDTM/ADaM specifications and datasets, developing SAS/R programs, and overseeing CRO deliverables. The opportunity is interesting as it offers a sponsor-dedicated position focused on clinical development and regulatory submissions.
Job Description
Sponsor-dedicated Principal Statistical Programmer working fully embedded within a pharmaceutical client to drive innovation in patient treatment.RequirementsGenerate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studiesDevelop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphsDeliver high-quality statistical programming results including 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 to ensure high-quality and meet the pre-specified timelinesSupport the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analysesUnderstand and follow FDA regulations which affect the reporting of clinical trial dataContribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macrosParticipate in the development of CRFs, edit check specifications, and data validation plansProvide review and/or author data transfer specifications for external vendor dataCollaborate with internal and external functions to ensure meeting project timelines and goalsProvide review and/or author SOPs and/or Work Instructions related to statistical programming practicesOriginally posted on Himalayas
Full Description
Sponsor-dedicated Principal Statistical Programmer working fully embedded within a pharmaceutical client to drive innovation in patient treatment.RequirementsGenerate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studiesDevelop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphsDeliver high-quality statistical programming results including 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 to ensure high-quality and meet the pre-specified timelinesSupport the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analysesUnderstand and follow FDA regulations which affect the reporting of clinical trial dataContribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macrosParticipate in the development of CRFs, edit check specifications, and data validation plansProvide review and/or author data transfer specifications for external vendor dataCollaborate with internal and external functions to ensure meeting project timelines and goalsProvide review and/or author SOPs and/or Work Instructions related to statistical programming practicesOriginally posted on Himalayas