Sr Associate Biostatistical Programming The Biostatistical Programming Senior Associate will work in Amgen's Global Randomization and Blinding (GRB) organization Responsibilities include: + 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 Knowledge: + 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 + Basic understanding of IRT systems preferred. + Drug development processes and operations Basic Qualifications: BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or related subject. At least four years of statistical programming experience in relevant career statistical programming experience in a clinical development setting. Preferred Qualifications: + MSc or higher degree in statistics, biostatistics, mathematics, or related subject + Six years of clinical research programming experience + Drug development in related industries + Project planning + Process improvement participation + Team participation and effectiveness