Job Details

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