Title - SAS Programming Director, Contract Position
Part time: 20 hours/week
Contract – 1 yr Duration
Qualifications:
•Extensive programming project experience in DIOTECH/pharmaceutical companies or CROs, with a strong background in oncology solid tumor clinical trials
•Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a Windows environment, with demonstrated mastery of SAS/STAT procedures
•Strong experience with CDISC SDTM and ADAM standards and familiarity with eCTD submission requirements
•Demonstrated success in managing programming deliverables across multiple studies and vendors
•Deep understanding of drug development and the biopharmaceutical industry
•Proven ability to manage multiple, competing priorities in a dynamic environment
•Excellent communication, collaboration, and organizational skills
•Self-motivated and results-oriented, with the ability to meet tight timelines
Advanced experience with:
•Constructing technical programming specifications
•Relational databases
•Good Clinical Practices (GCP)
•Good Programming Practices (GPP)
•21 CFR Part 11 Standards
•Integrated summary safety/efficacy analyses
•Safety data and coding dictionaries (MedDRA)
Responsibilities:
•Development and validation of technical programming specifications and programs
•Generation of SDTM and ADaM datasets
•Production of SAP-specific tables, listings, and figures
•Management and documentation of all statistical programming activities
•Implementation of process and technology improvements to enhance efficiency and quality
•Contribute to the development and maintenance of SOPs and guidelines for statistical programming and ensure adherence across projects
•Coordinate end-to-end programming deliverables in collaboration with cross-functional team members and vendors
•Collaborate closely with internal stakeholders (Biostatistics, Clinical, Medical, Regulatory) and external partners (Full-Service and Functional Service Providers)
•Ensure outsourced programming activities are performed according to GCP, approved SOPs, and study protocols
•Monitor vendor deliverables and quality, escalating issues when needed
•Support study- and program-level audit and inspection readiness activities
