– Onsite San Diego
– 6 month initial contract length
CDISC Experience required
NDA submission, ISS and ISE , big plus
• Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications.
• Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files.
• Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
• Maintain complete and auditable documentation of all programming activities.
• Review output across SAS programs to ensure consistency.
• Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
• Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
• Participate in the development and/or maintenance of departmental procedures and standards.
• Review CRFs, edit check specifications, and table mock-ups.
• Works effectively with cross functional groups, study team, and vendors.
• Participates in monitoring CRO activities and reviewing CRO deliverables as necessary.
• May assist in creation of table, figure, or listing mockups under supervision of statisticians.
• May train and mentor new programmers.
Other duties as assigned.
• Bachelor’s degree in Statistics, Mathematics, or Computer Science or in a related field.
• Minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
• Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
• Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
• Excellent communication and interpersonal skills to effectively interface with others.