Extensive knowledge of SAS Macros and related SAS technologies
Strong experience with R, Python, or Spotfire in validated settings
Familiar with ICH guidelines, CDISC standards, 21 CFR Part 11, and FDA guidelines
Must have eCTD NDA submission experience
Responsibilities
Ensure effective departmental training plans are in place
Perform vendor qualifications for statistical programming and manage CRO activities
Generate and review SDTM domains and ADaM datasets
Create and validate tables, figures, and listings for clinical trial data
Conduct quality control for SAS programs and various study documents
Maintain thorough documentation for all programming tasks
Manage datasets and outputs across multiple studies for consistency
Provide statistical programming support for pharmacovigilance and regulatory requests
Develop and maintain departmental procedures and programming standards
Review CRFs and related mock-up documents
Assist in SAS validation in accordance with 21 CFR Part 11
Train and mentor new programming team members
Benefits
Comprehensive training and development programs
Opportunities for leadership and mentoring roles
Engagement in cross-functional team projects
Support for pursuing advanced certifications or further education
Flexible working conditions in a dynamic environment
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
