Biostatistical Programming Senior Associate

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

Job summary

Amgen India (Hyderabad) seeks a Biostatistical Programming Senior Associate to support complex statistical analyses for clinical studies and regulatory submissions. You will perform hands-on programming, create SDTM/ADaM datasets, and generate tables, listings, and figures for safety and efficacy evaluations.

The role requires 4+ years in statistical programming within a clinical development environment, with expertise in SAS, R, and SDTM/ADaM standards.

Qualifications

• BA/BSc or higher in biostatistics, statistics, mathematics, computer science, or related quantitative field with 4+ years of statistical programming in clinical development.
• Experience with SDTM/ADaM data structures and clinical trial data analysis.
• Strong English communication and ability to deliver timely, quality outputs.

Responsibilities

• Analyze and report clinical trial data using SAS and/or R.
• Create and validate SDTM/ADaM datasets for safety and efficacy.
• Develop and validate tables, listings, and figures for analyses and regulatory submissions.
• Prepare statistical programming specifications and related regulatory documents.
• Maintain documentation and validation artifacts for audit readiness.
• Collaborate with cross-functional teams and support Study Lead Programmer as needed.

Skills

SAS

R

CDISC SDTM

CDISC ADaM

Define Standards

SAS/STAT

Data Quality

English Communication

Education

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

MSc in statistics/biostatistics (preferred)

Tools

SAS

R

Python

Job description

Career Category Clinical Job 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.

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 globallyAssist 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).

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

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 be 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