Biostatistical Programming Senior Associate

The Biostatistical Programming Senior Associate will work in Amgen's Global Randomization and Blinding (GRB) organization

• Creating and delivering Participant and Investigational Product (IP) randomization lists meeting specifications per randomization requests. Perform the duties of a Study Randomizer as needed
• Write and validate SAS programs to verify randomization assignments and dose decisions performed by an Interactive Response Technology (IRT) system throughout the conduct of a clinical trial.
• Function as a study programmer to manage IRT data transfer activities
• Act as a gatekeeper for IRT data transfers into Amgen’s secure File Transfer Protocol (sFTP) locations.
• Understand and execute both department and study level macros and utilities
• Ongoing verification of electronic systems used to execute randomization schedules and dosing algorithms
• Ensuring procedures are followed to maintain the study blind per Amgen Study Operating Procedures (SOPs) throughout the lifecycle of a study
• Maintaining accurate and complete documentation of randomization and blinding activities and communications
• Assist with study and systems audits by internal and external bodies and respond to audit questions and findings
• Participate in the development and review of GRB policies, manuals, SOPs and other controlled documents
• Cross functional training and presentations

• Biostatistical programming using SAS version 8.2 and higher or other programming languages (e.g. R or Python)
• Understanding of computer operating systems, including UNIX, preferred
• Project planning and management