Clinical SAS Programmer

Responsibilities:

• Support the Biostatistics team.
• Coordinating programming activities.
• Accessing and converting data to SAS from database management system and PC file formats.
• Working closely with clinicians, statisticians, and publication managers to generate QC outputs for publications.
• Review publications to ensure the accuracy, quality, and soundness of statistical methodologies.
• Coordinate utilization for publication and generate activities metrics.
• Providing input to the database and CRF development, creating edit check programs, and providing feedback to the data management.
• Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents.

Requirements:

• Minimum of bachelor's degree in Statistics, Computer Science, Mathematics, or a related science discipline.
• Minimum 10+ years' experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
• FDA submission experience preferred.
• Some project experience in a pharmaceutical/CRO programming environment or demonstrated leadership in a clinical pharmaceutical/CRO environment.
• Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, and MS Office.
• Experience in CDISC data standards, e.g., SDTM and ADaM
• Proven experience with Unix and Windows operating systems.
• Understanding of the software development life cycle.
• Understanding of FDA guidelines.