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 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
