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Sr. Statistical Programmer
Sr. Statistical ProgrammerRedbock - an NES Fircroft company • Fremont, CA, US
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Sr. Statistical Programmer

Sr. Statistical Programmer

Redbock - an NES Fircroft company • Fremont, CA, US
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

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 :

  • Support 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
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    Sr Statistical Programmer • Fremont, CA, US

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