Sr. Statistical Programmer (Sonoma)Redbock - an NES Fircroft company • Sonoma, CA, United States

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Sr. Statistical Programmer (Sonoma)

Redbock - an NES Fircroft company • Sonoma, CA, United States

7 days ago

Job type

Full-time

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 • Sonoma, CA, United States

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