Redbock - an NES Fircroft company
Sr. Statistical Programmer
Redbock - an NES Fircroft company, San Francisco, California, United States, 94199
Direct message the job poster from Redbock - an NES Fircroft company
Principal Recruitment Consultant - Biometrics Team Lead at Redbock - an NES Fircroft company 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
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Consulting
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Principal Recruitment Consultant - Biometrics Team Lead at Redbock - an NES Fircroft company 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
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Consulting
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr