Sr Associate Biostatistics

Amgen Inc. (IR); Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Amgen India (Hyderabad) is seeking a Biostatistics Senior Associate to provide hands-on statistical expertise across the drug development lifecycle. You will author and review SAPs, SDTM/ADaM documents, and collaborate with cross-functional teams to ensure rigor, regulatory compliance, and timely study outputs.

The role offers opportunities to lead statistical deliverables, advance trial methodology, and contribute to publications and regulatory submissions within a global biotech leader.

Qualifications

• Master’s degree in Statistics or Biostatistics with relevant post-graduate experience.
• PhD with 1 year post-graduate experience in statistics.
• Experience applying statistical methods in clinical trials.

Responsibilities

• Author and provide statistical contributions to SAPs, TFL shells, randomization specs, SDTM/ADaM, and other study docs.
• Conduct and document statistical analyses for clinical trials, including primary/secondary endpoints.
• Perform QC of datasets/outputs to ensure accuracy and CDISC compliance.
• Participate in CST meetings to provide statistical input.
• Collaborate with programming for timely study outputs.
• Contribute to clinical publications, study reports, and regulatory submissions.
• Review deliverables from external suppliers for quality.
• Stay updated on new methodologies and regulatory guidelines.

Skills

SAS

R

Statistical programming

English communication

Education

Master’s degree in Statistics/Biostatistics

Doctoral degree in Statistics/Biostatistics

Tools

CDISC SDTM/ADaM

AI/automation tools

Job description

Career Category Clinical Development Job Description Job Description Job Description 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. Biostatistics Sr Associate

What you will do

Let’s do this. Let’s 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 Amgen’s 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

Master’s 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

• Master’s 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 . 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