Biostatistics Sr Assoc (Study Statistician) Professional
Amgen · Hyderabad · onsite · Posted 72d ago
Undisclosed2–6 yrsfulltimeSourced from
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About this role
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 4 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 2 years 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 6+ years post-graduate experience, or Doctorate with 4+ 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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Skills
tablesWritingdrug developmentadamclinical trialsClinicalStatistical programmingrstatisticsSdtmApplicationbase sasBiostatisticsCdiscSASrandomizationRegulatory ComplianceResearchcomplianceArtificial Intelligence
About Amgen
Amgen
Biotechnology
1.5k+
employees
1980
46 years old
Hyderabad, Telangana
India
About
Amgen operates in the biotechnology sector, developing and delivering advanced medicines to address critical health challenges globally.
Industries
BiotechnologyBiotech & Life sciences
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