BiostatisticalProgrammingSeniorAssociate

## **Career Category** Research ## ## **Job Description** _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:_ * 5-9 years of overall experience * BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or related