Statistical Programmer (SP)

Provide Programming proficiency to develop and maintain programs to meet internal and external standards. Provide and assist in the development of project-related solutions to a wide range of statistical programming tasks.

Responsibilities:

• Working to ICH GCP and other applicable industry standards
• Review the respective study protocol/CRF
• Creation /Review of annotated CRFs
• Creation /Review of Data specifications
• Develop edit checks programming per the data validation plan or data management plan
• Write SAS programs to generate tables, listings, and figures and analysis datasets
• Develop programming for CDISC deliverables (SDTM, ADaM and define.xml)
• Communicate with programming and statistics leads
• Assist in the development of programming documentation including specifications, as appropriate, under supervision
• Reconciliation of external data
• Perform quality control on final datasets, reports
• Prepare and review Data Transfer Agreements
• Develop SAS macros as needed
• Understand and adhere to organization defined standard operating procedures (SOPs)
• Fulfil project responsibilities at the level of assisting the statistical programming lead

Education:

Master s / bachelor s degree computer science or biostatistics or related field.

Experience & Skills:

• 2-year relevant experience; or equivalent combination of education, training and experience
• Experience in SAS programming for multiple phase clinical trials in a pharmaceutical/CRO environment
• Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. Proven experience with Unix, Linux and Windows operating systems
• Proficient in written and oral communication