Biostatistical Programming Senior Associate

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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