Biostatistical Programming Senior Associate

Career Category

Clinical Development

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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