Biostatistical Programming Associate
At a glance
Junior Data Science role at Amgen. Hyderabad · full-time.
Pay not stated Data Science salary
dataroles summary, based on the employer's posting.
What you'll do
- Analyze clinical-trial data and prepare study reports using SAS, R or both
- Build and check safety and efficacy datasets, including SDTM and ADaM formats
- Produce and validate tables, listings and figures for safety and efficacy analyses
- Keep tracking and validation records, and write or check programs that test data quality
- Work with study colleagues across functions and regions on statistical programming tasks
What you bring
- A quantitative or scientific degree and at least three years of statistical programming in clinical development
- Hands-on ability to manipulate, analyze and report clinical-trial data, with familiarity with drug development
- Working knowledge of CDISC SDTM and familiarity with ADaM and Define standards
- Strong written and spoken English, and the ability to manage several projects with global teams
Who this fits
This role suits someone with clinical-development programming experience who can deliver accurate work to tight timelines. It is based in Hyderabad and involves collaboration with colleagues in different regions.
From the employer
Career Category
ClinicalJob Description
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
What you will do
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.
Responsibilities:
- 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
What we expect of you
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.
Basic Qualifications:
- 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
Preferred 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
What you can expect of us
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
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