Biostatistical Programming Senior Associate

Amgen; Hyderabad; On-site; INR 800,000 - 1,200,000; Full time

Benefits offered by this job

Generous Total Rewards Plan

Opportunities for career growth

Inclusive workplace culture

Job summary

A leading biotechnology company is seeking a Biostatistical Programming Senior Associate in Hyderabad, India. This role involves statistical programming for clinical trials using SAS and R. Responsibilities include data analysis, validation of datasets, and documentation for regulatory submissions. Candidates should have a relevant degree and experience in statistical programming. Join a diverse team committed to elevating patient care and advancing global health through innovative solutions.

Qualifications

• 4+ years of statistical programming experience in a clinical development environment.
• Familiarity with drug development life cycle and excellent skills in complex clinical trial data.
• Ability to work effectively in a global team environment.

Responsibilities

• Analyze and report clinical trial data using SAS and/or R.
• Create and validate SDTM and ADaM datasets.
• Prepare programming specifications and documentation.

Skills

Statistical programming

SAS

R

Data analysis

Communication skills

Education

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

MSc in statistics or related field

Tools

CDISC SDTM standards

Statistical tools

Data quality tools

Job description

Biostatistical Programming Senior Associate

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 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).

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 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 familiarity 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

• 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