Biostatistical Programming Senior Associate (Innovation)

Amgen Inc. (IR); Telangana; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Amgen India in Hyderabad seeks a Biostatistical Programming Senior Associate to expand automation and scalable solutions for clinical trial programming. You will balance innovation with regulatory-ready output, supporting data management, reporting, and submissions.

The role emphasizes building systems, workflows, and AI-enabled tools rather than solely performing hands-on programming, while collaborating with global teams on complex datasets.

Qualifications

• Bachelor’s degree in biostatistics or related quantitative field with at least 4 years of statistical programming experience.
• Familiarity with drug development lifecycle and complex data handling.
• Ability to deliver quality outputs on tight timelines.

Responsibilities

• Analyse and report clinical trial data using SAS/R/Python.
• Create and validate SDTM/ADaM datasets for safety and efficacy.
• Prepare programming specifications and regulatory submission documents.
• Collaborate with cross-functional teams globally to improve workflows.
• Design scalable programming solutions and automation tools.

Skills

Biostatistics

Statistical Programming

SAS

R

Python

CDISC Standards

English Communication

Education

Bachelor's degree in biostatistics or related field

Tools

SAS

R

Python

CDISC SDTM

Git

Job description

Career Category Clinical Job Description Biostatistical Programming Senior Associate (Innovation)

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 (Innovation)

NOTE: THIS ROLE DIFFERS FROM A TRADITIONAL STATISTICAL PROGRAMMING POSITION.

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 focus on developing programming efficiencies, automation solutions, and innovative tools that enhance productivity and scalability across programming teams.

This position is ideal for candidates who enjoy building systems and optimizing workflows-not for those primarily seeking to 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 or Python
• 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
• Design, build, and maintain programming solutions and tools that improve efficiency and quality across statistical programming ecosystems.
• Contribute to the full development lifecycle—from requirements gathering and design through testing, deployment, and maintenance.
• Collaborate with programming teams across center for design and analysis (CfDA) to identify process gaps and prototype scalable solutions using modern programming practices.
• Support federated innovation-integrating ideas and code contributions from other programming teams into unified, CfDA-wide solutions.
• Automate repeatable programming tasks and establish standards for modular, reusable code.
• Leverage AI and machine learning capabilities, including developing and deploying AI agents or copilots, to optimize programming workflows and knowledge sharing.
• Create and maintain clear, version-controlled documentation, training materials, and user guides to enable sustainable adoption of new tools.
• Participate in ongoing evaluation and enhancement of tools, ensuring continued performance, security, and relevance.
• Collaborate with cross-functional partners to align innovations with business needs and technical standards.

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

• Bachelor's or higher degree in biostatistics, statistics, mathematics, AI and data science, 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
• Familiar with data quality and compliance check tools
• Excellent oral and written English communication skills

Preferred Skills

• Masters or higher degree in statistics, biostatistics, mathematics, AI and data science, computer science or related quantitative or scientific subjects
• Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming
• Experience developing or maintaining solutions through a structured software development lifecycle (SDLC).
• Experience: SAS macro development R/Python Package development
• Working knowledge of version control (e.g., Git) and collaborative coding practices.
• Familiarity with AI and machine learning frameworks (e.g., OpenAI API, or custom model training).
• Building or implementing AI-driven programming assistants, copilots, or agents for workflow optimization.
• Working knowledge of Agile project management and collaborative development environments.

Competencies

• Strong programming (e.g., SAS, R, SQL, Python) and analytic skills
• Innovation and problem solving
• Strong documentation and communication skills
• Collaboration and teamwork across functions
• Organization and follow-through in structured projects
• AI and automation mindset
• Learning agility and curiosity

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.

A biotechnology pioneer since 1980, Amgen has grown to one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen