Sr. Statistical ProgrammerRedbock - an NES Fircroft company • Fremont, CA, US
Sr. Statistical Programmer
Redbock - an NES Fircroft company • Fremont, CA, US
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job_description.job_card.job_descriptionSupport statistical programming activities for clinical studies, ensure statistical programming deliverables are delivered within timelines Maintain statistical programming standards, processes, and SOPs Manage, review, and / or execute statistical programming deliverables for planned statistical analysis related to study monitoring, clinical study reports, data integrations, and regulatory query responses, covering multiple studies Generate TFLs to support ad hoc requests Review data management documents (CRF specification, data transfer agreements, DMP, annotated CRF), SDTM and ADaM specification, SAP, and TFL shells to provide statistical programming feedback
Overview :
Our client is seeking a Senior Statistical Programming consultant with recent experience leading a submission. This individual will play a critical role in driving Statistical Programming e- submission activities.
Qualifications :
- 12+ years of statistical programming experience in the pharma or biotech company, ideally within a small sponsor environment
- Must be able to independently develop SDTM and ADaM specifications (DDT) and program, develop and validate TFLs
- Proven experience leading and managing statistical programming activities for regulatory submission including but not limited to :
- Define.xml, SDRG, ADRG, and Pinnacle 21 Enterprise
- ISS / ISE integration and define package preparation
- Annotated CRF development and data handling / imputation methods
Key Responsibilities :
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Sr Statistical Programmer • Fremont, CA, US
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