Senior Statistical Programmer

Responsibilities :

• Ensure departmental or functional training plans in place and appropriate
• Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time deliverables within budget
• Generate, validate, and / or review SDTM domains and ADaM datasets and associated specifications
• Generate, validate, and / or review tables, figures and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications
• Generate or perform quality control for SAS programs and other study documents (, presentations and reports)
• Maintain complete and auditable documentation of all programming activities
• Manage datasets and output across SAS programs, studies, and indications to ensure consistency
• Manage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requests
• Manage programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures
• Develop and / or maintain departmental procedures and standards
• Review CRFs, edit check specifications, and table, figure, and listing mock-ups
• Manage, generate, and / or review , , , and reviewer's guide documents
• Assist in validation of SAS per CFR Part
• Train and mentor new members and programmers; supervise contract programmers, as needed

Requirements :