Senior Analyst/Programmer - Katalyst Healthcares & Life Sciences

• Overseeing SAS programming activities from varying aspects: programming, statistical and clinical
• Create, manage, and maintain the SAS programming algorithm for the clinical study database and data analysis
• Peer review the submission packages and contribute to the input of SAP and mock TFLs
• Perform ad hoc analyses to support Phase I to IV clinical trials and medical publications
• Maintain relationships with internal and external customers and vendors
• Mentor up and coming junior programmers and analysts
• Tracking projects against goals and submit status reports to project management

Requirements:

• Bachelor's or advanced degree in statistics, biostatistics, computer science or related fields
• 4 to 6 years' experience in the pharma/biotech industry
• Advanced SAS programming skills (e.g, SAS SQL, SAS Macro, SAS/STAT, SAS/GRAPH, etc.) with clinical trial data
• Advanced knowledge in industry standards, such as the ICH guidelines, CDISC standards, 21 CFR Part 11, and FDA guidelines
• Experience in handling and processing upstream data, e.g., EDC, eDT, SDTM, and in providing outputs to meet downstream requirements, e.g., ADaM, define.xml and TFLs