About the role
Career Category
Clinical DevelopmentJob 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
Skills & Tags
Aplyr's read
Amgen is a biotechnology leader focused on innovative therapeutics in oncology, cardiovascular, and inflammation, attracting professionals in science, engineering, and data analytics.
What's promising
- •Strong focus on cutting-edge biotechnology and human therapeutics.
- •Diverse career opportunities in scientific, engineering, and data roles.
- •Commitment to addressing serious health conditions like cancer and cardiovascular disease.
What to watch
- •Highly competitive industry with constant innovation demands.
- •Regulatory challenges in developing and marketing new therapies.
- •Potential for high-pressure work environment due to ambitious goals.
Why Amgen
- •Pioneering in biologic therapies with a focus on serious diseases.
- •Robust pipeline of innovative drugs in various therapeutic areas.
- •Global presence with a strong emphasis on research and development.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Amgen
Amgen is a leading biotechnology company that discovers, develops, manufactures, and delivers innovative human therapeutics. The company focuses on areas such as oncology, cardiovascular disease, and inflammation.
