Principal 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 (e.g., 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 acrf.pdf, define.xml, define.pdf, and reviewer's guide documents.
• ssist in validation of SAS per 21 CFR Part 11.

Requirements :