Biostatistical Programming Associate

Amgen SA; Hyderabad; On-site; INR 1,000,000 - 1,800,000; Full time

Job summary

Amgen India (Hyderabad) is seeking a Biostatistical Programming Associate to support statistical data analysis for phase 1–4 studies and regulatory submissions. You will perform analyses using SAS and/or R, create and validate SDTM/ADaM datasets, and prepare tables, listings, and figures while ensuring data quality in a global cross-functional setting.

The role requires a strong foundation in biostatistics and hands-on clinical programming experience, with a focus on timely, high-quality outputs

Qualifications

• BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or related fields, with at least 3 years of statistical programming experience.
• Familiarity with drug development lifecycle and excellent skills with manipulation, analysis and reporting of clinical trials data.
• Ability to provide quality output and deliverables within challenging timelines.
• Ability to work effectively in a globally dispersed team environment with cross-cultural partners.
• Working knowledge of CDISC SDTM, and familiarity with CDISC ADaM and Define standards; ability to implement them.
• Familiar with data quality and compliance check tools.
• Excellent oral and written English communication skills.

Responsibilities

• Analyze and report clinical trial data using SAS and/or R.
• Create and validate SDTM, ADaM, and other analysis datasets for safety and efficacy.
• Create and validate tables, listings, and figures for safety and efficacy.
• Maintain tracking and validation documentation.
• Collaborate with cross-functional teams to check data quality and validate programs.
• Interact with study team members from other functions globally.

Skills

SAS

R

Python

CDISC SDTM

ADaM

Education

BA/BSc or higher in biostatistics/ statistics/ mathematics/ computer science

MSc or higher in statistics/ biostatistics (preferred)

Tools

Define standards

Job 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

Lets do this. Lets 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