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 . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen