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**
