Senior Associate – Biostatistics (Study Statistician)
Location: Hyderabad, India
Work Mode: On-site
Employment Type: Full-Time
Job ID: R-233541
Function: Clinical Biostatistics
Job Overview
Amgen is expanding its global Biostatistics capabilities, with Amgen India (Hyderabad) playing a strategic role in integrated clinical development delivery. We are seeking a Senior Associate – Biostatistics (Study Statistician) to provide hands-on statistical expertise across the clinical trial lifecycle, supporting high-quality, compliant, and timely drug development programs.
This role offers strong exposure to clinical trial methodology, statistical analysis, regulatory submissions, and cross-functional collaboration, making it ideal for statisticians looking to grow within a global biopharmaceutical organization.
Key Responsibilities
Author and contribute to Statistical Analysis Plans (SAPs), TFL shells, randomization specifications, and submission-ready datasets (SDTM/ADaM)
Perform statistical analyses for primary, secondary, and exploratory endpoints across clinical studies
Conduct and document quality control (QC) of datasets and statistical outputs in alignment with CDISC standards
Collaborate closely with statistical programmers to ensure timely and accurate delivery of study outputs
Participate in Clinical Study Team (CST) meetings, providing expert statistical input
Support preparation of clinical study reports (CSRs), regulatory submissions, and scientific publications
Review deliverables from external vendors and CRO partners to ensure quality and compliance
Maintain statistical documentation within the Trial Master File (TMF)
Stay current with evolving regulatory guidelines, statistical methodologies, and analytical tools
Support audits and inspections by adhering to internal SOPs and regulatory requirements
Required Education & Experience
Education:
Master’s degree in Statistics, Biostatistics, or a related quantitative discipline with strong statistical content
Doctoral degree (PhD) in Statistics/Biostatistics is an added advantage
Experience Required:
2+ years of post-graduate experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry (Master’s level), OR
1+ year of post-doctoral industry experience (PhD level)
Preferred:
4+ years (Master’s) or 2+ years (PhD) of relevant industry experience
Prior ownership or leadership of at least one clinical study or project
Technical & Professional Skills
Proficiency in statistical programming using SAS and/or R
Strong understanding of clinical trial design, conduct, and analysis
Hands-on experience with CDISC standards (SDTM, ADaM)
Experience authoring or reviewing protocols, SAPs, and CSRs
Familiarity with AI-driven or automation tools for statistical efficiency is desirable
Excellent written and verbal communication skills in English
Strong analytical thinking, attention to detail, and collaborative mindset
Why Join Amgen
Be part of a global biostatistics organization driving innovative drug development
Work on studies impacting millions of patients worldwide
Access continuous learning, career development, and global mobility opportunities
Inclusive, collaborative work culture with a strong focus on employee well-being
Competitive total rewards covering health, financial security, work-life balance, and career growth
Apply now on thepharmadaily.com to advance your career in Clinical Biostatistics, Statistical Programming, and Drug Development Research with a leading global biotechnology organization.
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