Strong knowledge of SAS Macros, Base SAS, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS
Experience with additional programming languages or software, particularly R, Python, or Spotfire
Familiarity with ICH guidelines, CDISC standards, 21 CFR Part 11, and FDA guidelines
eCTD NDA submission experience is essential.
Responsibilities
Ensure effective departmental training plans are established
Oversee vendor qualifications for statistical programming and manage CRO programming issues for timely, budget-compliant deliverables
Generate, validate, and review SDTM domains and ADaM datasets
Create and confirm tables, figures, and listings for clinical trial data analysis
Develop, validate, and control SAS programs and other study documentation
Maintain thorough records of all programming activities
Consistently manage datasets across SAS programs and clinical studies
Support statistical programming for pharmacovigilance and ad hoc requests
Oversee programming, testing, and documentation of SAS global utility programs
Establish and update departmental procedures and standards
Review CRFs and specifications for accuracy
Generate and review essential regulatory documents
Assist in SAS validation per 21 CFR Part 11
Train, mentor, and potentially supervise new programmers.
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
