Sr. Associate Biostatistics

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).

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 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:

• Masters 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.