Clinical SAS Programmer

Responsibilities:

• Independently develop/validate programs that generate SDTM and analysis datasets based on Adam specifications.

• Prepare/QC Adam datasets documentation: Define.xml, Reviewer's Guide and analysis metadata report.

• Independently develop/validate programs that generate tables and listings specified in the protocol or the Statistical Analysis Plan. (SAP)

• Perform quality control on final reports.

• Provide QC and validation reports.

• Support development of technical programming specifications for Adam standards.

• Communicate with programming and statistics leads, data managers and other team members.

• Provide project progress updates of programming activities.

Requirements:

• BS/MS in Statistics, Biostatistics, Computer Science, Mathematics or Life Sciences.

• 10+ years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.

• Strong SAS programming skills required in Windows & UNIX environment with proficiency in SAS/Base, SAS Macros, SAS/Stat.

• Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide and SAS Studio is a plus.

• Experience with all clinical phases I, II, III and IV of trials is desirable.

• Good understanding of standards specific to clinical trials such as CDISC, SDTM, Adam, MedDRA, WHODRUG.

• Strong problem-solving skills.

• Good organizational and time management skills.

• Excellent communication skills and capability of communicating technical concepts.

• Excellent organizational skills demonstrated success to multi-task and deliver viable solutions in a fast-paced environment with changing priorities.