Extensive knowledge of SAS Macros highly preferred
Experience with additional languages/software (R, Python, Spotfire) in validated environments is strongly preferred
Demonstrates extensive knowledge of industry standards, including ICH guidelines, CDISC standards, 21 CFR Part 11, and FDA guidelines
eCTD NDA submission experience is a must.
Responsibilities
Ensure departmental training plans are in place and appropriate
Perform vendor qualifications for statistical programming and manage CRO programming issues
Generate, validate, and review SDTM domains and ADaM datasets and specifications
Generate, validate, and review tables, figures, and listings for clinical trials data
Generate or perform quality control for SAS programs and study documents
Maintain complete and auditable documentation of all programming activities
Manage datasets and outputs across SAS programs for consistency
Provide statistical programming support for supplemental or exploratory analyses
Manage programming, testing, and documenting SAS global utility programs and tools
Develop and maintain departmental procedures and standards
Review CRFs, edit check specifications, and mock-ups
Manage and review acrf.pdf, define.xml, and reviewer's guide documents
Assist in validation of SAS per 21 CFR Part 11
Train and mentor new members and programmers; supervise contract programmers as needed
Full Job Description
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
Extensive knowledge of SAS Macros highly preferred, in addition to knowledge of Base SAS, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS
Experience working with other languages or software (R, Python, Spotfire) in validated environments is strongly preferred
Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines
