Sr Associate Biostatistics

<h2><b>Career Category</b></h2>Clinical Development<h2></h2><h2><b>Job Description</b></h2><div>Job Description<div>Job Description</div></div><div><div><div><div><div><div><div><div><div><p><b>HOW MIGHT YOU DEFY IMAGINATION?</b></p><p>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.</p><p></p><p><b>Biostatistics Sr Associate</b></p><p><b>What you will do</b></p><p>Let’s do this. Let’s change the world.</p><p>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.</p><p></p><p>This role provides an opportunity to gain breadth across statistical deliverables while developing depth in clinical trial methodology, programming, and cross-functional teamwork.</p><p></p><p><b>Responsibilities:</b></p><ul><li><p>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.</p></li><li><p>Conduct and document statistical analyses for clinical trials, including primary and secondary endpoint analyses, exploratory analyses, and dose-level review support.</p></li><li><p>Perform and document quality control (QC) of datasets and outputs to ensure accuracy, consistency, and compliance with CDISC standards.</p></li><li><p>Participate in Clinical Study Team (CST) meetings to provide statistical input and represent Biostatistics.</p></li><li><p>Collaborate with programming colleagues to ensure timely delivery of study outputs.</p></li><li><p>Contribute to clinical publications, study reports, and regulatory submissions.</p></li><li><p>Support the review of deliverables from external suppliers for quality.</p></li><li><p>Stay abreast of new methodologies, tools, and regulatory guidelines in statistical practice.</p></li><li><p>Ensure that statistical sections of the Trial Master File (TMF) are maintained and up to date.</p></li><li><p>Adhere to Amgen’s policies, SOPs, and relevant controlled documents, and support audits as needed.</p></li></ul><p></p><p>This position is currently located at Amgen India (Hyderabad).</p><p></p><p><b>Win</b></p><p><b>What we expect of you</b></p><p>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.</p><p></p><p></p><p></p><p><u>Basic Qualifications</u>:</p><ul><li><p>Master’s degree in Statistics/Biostatistics (or related subject with high statistical content) with <b>2 years post-graduate experience</b> as a statistician in the pharmaceutical industry or medical research, <b>OR</b></p></li><li><p>Doctoral degree in Statistics/Biostatistics (or related subject with high statistical content) with <b>1 year post-graduate experience</b>.</p></li><li><p>Competency in statistical programming (SAS or R).</p></li><li><p>Experience applying statistical methods in the analysis and conduct of clinical trials.</p></li><li><p>Ability to clearly communicate in English, both written and oral.</p></li></ul><p></p><p><u>Preferred Skills</u>:</p><ul><li><p>Master’s degree with <b>4&#43; years</b> post-graduate experience, or Doctorate with <b>2&#43; years</b>.</p></li><li><p>Prior leadership of at least 1 study/project with minimal oversight.</p></li><li><p>Experience authoring protocols, SAPs, and reviewing CSRs.</p></li><li><p>Familiarity with CDISC standards (SDTM, ADaM).</p></li><li><p>Experience with AI/automation tools to drive efficiency.</p></li><li><p>Strong understanding of drug development and statistical applications across the clinical lifecycle.</p></li></ul><p></p><p><b>Thrive</b></p><p><b>What you can expect of us</b></p><p>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.</p><ul><li><p>Vast opportunities to learn and develop within our global organization</p></li><li><p>Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act</p></li><li><p>Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits</p></li></ul></div></div></div></div></div></div></div></div></div><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.