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Responsibilities:

• Apply SAS programming and analytical skills using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS
• Design, develop, evaluate, validate, and modify computer programs using SAS to analyze clinical data.
• Produce and deliver standard datasets, program edit checks, quality tables, figures and listings in a timely and high-quality fashion.
• Create and validate CDISC standard datasets.
• Provide input in the design and development of clinical trial protocols, case report forms and clinical databases.
• Work closely with clinical operations, data management and statisticians to generate statistical output - tables/listing/figures.
• Liaise with vendors as needed to facilitate electronic data transfers and statistical programming.

Requirements:

• Good project management skills, CRO oversight skills, professional attitude, self-improvement mentality with positive attitude
• Good written and oral presentation skills and ability to communicate effectively.
• Ability to think creatively and independently, form sound opinions, and make sensible decisions in a dynamic environment.
• Strong interpersonal, organizational, and multi-tasking skills
• Excellent attention to detail and problem-solving skills.
• Master's degree with strong analytical skills
• 5+ years in a pharmaceutical/biotech or CRO setting preferably with Phase III trial experience.
• Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials.
• Thorough knowledge of SDTM and ADaM data sets, MACROS, T/L/Gs and CDISC theory and implementation guidelines
• R programming experience a plus