Biostatistical Programming Senior Associate
At a glance
Senior 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 the statistical outputs used in studies and regulatory submissions
- Build and check safety and efficacy datasets, including SDTM and ADaM formats
- Produce and validate tables, listings and figures for clinical studies
- Write programming specifications and submission documents, while keeping validation and tracking records
- Check data quality with cross-functional teams and back up the Study Lead Programmer when needed
What you bring
- A relevant quantitative or scientific degree and at least four years of clinical-development statistical programming experience
- Strong SAS/STAT skills and the ability to work with complex clinical trial data
- Working knowledge of current CDISC SDTM requirements, plus familiarity with ADaM and Define
- English communication skills and the ability to deliver accurate work across competing projects and timelines
Who this fits
This role suits a hands-on programmer comfortable supporting clinical studies and regulatory submissions across therapeutic areas. You’ll work with colleagues in a globally distributed, cross-cultural team. The position is based in Hyderabad, India.
From the employer
Career Category
ClinicalJob Description
Biostatistical Programming Senior 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.
Biostatistical Programming Senior 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 Senior Associate, you will perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions.
Key Responsibilities:
- Analysis and reporting of clinical trial data using SAS and/or R
- Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy
- Creation and validation of complex tables, listings, and figures, both safety and efficacy
- Prepare statistical programming specifications
- Prepare statistical programming related documents for regulatory submissions
- Maintain tracking and validation documentation
- Collaborate with cross-functional team and create and/or validate complex programs for checking data quality
- Interact and collaborate with study team members from other functions globally
- Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP
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 4 years of statistical programming experience in relevant career statistical programming experience in a clinical development environment.
- Familiarity with drug development life cycle and excellent skills with the manipulation, analysis and reporting of complex clinical trial data
- Ability to effectively perform complex statistical programming and related tasks
- Ability to provide quality output and deliverables in adherence with challenging timelines
- Ability to work effectively on multiple tasks or projects across therapeutic areas
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
- Working knowledge of latest CDISC SDTM standards and familiar with CDISC ADaM and Define standards with strong ability to implement the standards
- In depth knowledge of SAS/STAT packages
- 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
- Prior regulatory submission experience for drug approval
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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