Biostatistical Programming Senior Associate Job at Amgen (Hyderabad)

Job Description

The Biostatistical Programming Senior Associate will work in Amgen's Global Randomization and Blinding (GRB) organization

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

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
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

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