About this role
Career Category Clinical Development 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: 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 environment.
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
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