Sr Associate Biostatistics
At a glance
Senior Data Science role at Amgen. Hyderabad · full-time.
Pay not stated Data Science salary
dataroles summary, based on the employer's posting.
What you'll do
- Write or review study plans, table and figure shells, randomization instructions, and submission data specifications
- Analyze clinical-trial endpoints and exploratory questions, documenting methods and supporting dose-level reviews
- Check datasets and statistical outputs for accuracy, consistency, and alignment with CDISC standards
- Bring statistical input to study-team discussions and coordinate with programmers to deliver study outputs on time
- Support publications, study reports, regulatory submissions, supplier reviews, and upkeep of statistical Trial Master File materials
What you bring
- A statistics or biostatistics master’s degree, or a related degree with substantial statistics, plus two years’ relevant postgraduate work
- Alternatively, a doctorate in statistics, biostatistics, or a related field with substantial statistics, plus one year of relevant postgraduate work
- You can program in SAS or R, apply statistical methods to clinical trials, and communicate clearly in spoken and written English
Who this fits
This suits a biostatistician seeking hands-on work across clinical studies, from analysis and programming collaboration to regulatory documentation. The position is based in Hyderabad, India.
From the employer
Career Category
Clinical DevelopmentJob Description
Job DescriptionJob DescriptionHOW 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
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