Sr Associate Biostatistics

Amgen Technology; Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Amgen India in Hyderabad is seeking a Biostatistics Senior Associate to provide hands-on statistical expertise across the drug development lifecycle, author SAPs, TFLs, SDTM/ADaM, and support regulatory submissions.

You will collaborate across functions, perform analyses, QC datasets, contribute to publications, and stay current with CDISC standards and new methodologies.

A Masters with 2 years or Doctoral with 1 year, SAS or R proficiency, and strong English communication are required.

Qualifications

• Masters with 2 years post-graduate experience in pharma or medical research.
• Doctoral degree with 1 year post-graduate experience.
• Proficiency in SAS or R and statistical programming.
• Strong communication in English (written and spoken).

Responsibilities

• Author SAPs, TFL shells, SDTM/ADaM specs and other study documents.
• Perform primary/secondary endpoint analyses and dose-level reviews.
• QC datasets and outputs for CDISC compliance and accuracy.
• Participate in CST meetings to provide statistical input.
• Collaborate with programming to ensure timely study deliverables.
• Contribute to publications, study reports, and regulatory submissions.
• Audit deliverables from external suppliers and stay updated on guidelines.

Skills

Statistical analysis

English communication

Leadership

Education

Masters in Statistics/Biostatistics

Doctoral degree in Statistics/Biostatistics

Tools

SAS

R

Job description

Job DescriptionJob Description

HOW MIGHT YOU DEFY IMAGINATION

If you feel like youre part of something bigger, its 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 worlds leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Biostatistics Sr Associate

What you will do

Lets do this. Lets change the world.

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. As a Biostatistics Senior Associate, you will provide hands-on statistical expertise to clinical studies across the drug development lifecycle. You will author and review statistical documents, perform data analyses, and collaborate cross-functionally to ensure scientific rigor, regulatory compliance, and timely delivery of study outputs.

This role provides an opportunity to gain breadth across statistical deliverables while developing depth in clinical trial methodology, programming, and cross-functional teamwork.

Responsibilities:

• Author and provide statistical contributions to Statistical Analysis Plans (SAPs), Table/Figure/Listing (TFL) shells, randomization specifications, submission data file specifications (SDTM/ADaM), and other key study-related documentation.

• Conduct and document statistical analyses for clinical trials, including primary and secondary endpoint analyses, exploratory analyses, and dose-level review support.

• Perform and document quality control (QC) of datasets and outputs to ensure accuracy, consistency, and compliance with CDISC standards.

• Participate in Clinical Study Team (CST) meetings to provide statistical input and represent Biostatistics.

• Collaborate with programming colleagues to ensure timely delivery of study outputs.

• Contribute to clinical publications, study reports, and regulatory submissions.

• Support the review of deliverables from external suppliers for quality.

• Stay abreast of new methodologies, tools, and regulatory guidelines in statistical practice.

• Ensure that statistical sections of the Trial Master File (TMF) are maintained and up to date.

• Adhere to Amgens policies, SOPs, and relevant controlled documents, and support audits as needed.

This position is currently 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 strategic Biostatistics leader with a passion for tech-enabled transformation.

Basic Qualifications:

• Masters degree in Statistics/Biostatistics (or related subject with high statistical content) with 2 years post-graduate experience as a statistician in the pharmaceutical industry or medical research, OR

• Doctoral degree in Statistics/Biostatistics (or related subject with high statistical content) with 1 year post-graduate experience.

• Competency in statistical programming (SAS or R).

• Experience applying statistical methods in the analysis and conduct of clinical trials.

• Ability to clearly communicate in English, both written and oral.

Preferred Skills:

• Masters degree with 4+ years post-graduate experience, or Doctorate with 2+ years.

• Prior leadership of at least 1 study/project with minimal oversight.

• Experience authoring protocols, SAPs, and reviewing CSRs.

• Familiarity with CDISC standards (SDTM, ADaM).

• Experience with AI/automation tools to drive efficiency.

• Strong understanding of drug development and statistical applications across the clinical lifecycle.

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 develop within 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