Amgen
From Amgen's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
Statistical Programming Associate What you will do Let’s do this.
Biostatistical Programming Associate
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
Statistical Programming Associate
Let’s do this. Let’s change the world.
Amgen is expanding its Global Statistical Programming capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Associate, you will perform hands on statistical programming activities to support statistical data analysis of phase 1 to 4 clinical studies and regulatory submissions.
Analysis and reporting of clinical trial data using SAS and/or R
Creation and validation of SDTM, ADaM, and other analysis datasets, both safety and efficacy
Creation and validation of tables, listings, and figures, both safety and efficacy
Maintain tracking and validation documentation
Collaborate with cross-functional team and create and/or validate programs for checking data quality
Interact and collaborate with study team members from other functions globally
This position will be located at Amgen India (Hyderabad).
Win
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a results-oriented, tech-forward programming leader with deep expertise in clinical trial operations and digital transformation.
BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 3 years of statistical programming experience in clinical development environment.
Familiarity with drug development life cycle and excellent skills with manipulation, analysis and reporting of clinical trials data
Ability to provide quality output and deliverables, in adherence with challenging timelines
Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
Ability to work effectively on multiple tasks or projects
Working knowledge of latest CDISC SDTM standards and familiar with CDISC ADaM and Define standards, with ability to implement the standards
Familiar with data quality and compliance check tools
Excellent oral and written English communication skills
MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects
Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming
In depth knowledge of SAS/STAT packages
Prior regulatory submission experience
Thrive
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
.
Scores your resume against this job the way resume scanners do: the job's hard and soft skills, searchability, recruiter tips and formatting.
Create a free account to see your score. Your resume stays in this browser until then, and we never store it.
Already a member? Sign in