Job Title: Senior Associate Biostatistics (Study Statistician)
Location: Hyderabad, India
Company: Amgen
Employment Type: Full-Time
Experience Required: 2–4 years in biostatistics/statistical programming within the pharmaceutical or clinical research industry
Amgen is seeking a Senior Associate Biostatistician to join its expanding global Biostatistics team in Hyderabad, India. This role is integral to supporting clinical studies across the drug development lifecycle, providing statistical expertise, authoring and reviewing key statistical documents, performing analyses, and ensuring compliance with regulatory and industry standards.
This position offers an opportunity to gain broad experience across clinical trial methodology, statistical programming, and cross-functional collaboration while developing expertise in advanced statistical techniques and clinical trial operations.
Statistical Analysis & Documentation: Author and review Statistical Analysis Plans (SAPs), Table/Figure/Listing (TFL) shells, randomization specifications, submission data file specifications (SDTM/ADaM), and other study documentation.
Data Analysis & Quality Control: Conduct statistical analyses for clinical trials, including primary, secondary, and exploratory endpoints. Ensure accuracy and consistency of datasets and outputs through rigorous quality control (QC) processes.
Cross-functional Collaboration: Participate in Clinical Study Team (CST) meetings, provide statistical guidance, and collaborate with programming colleagues to ensure timely delivery of outputs.
Regulatory Support: Contribute to clinical study reports, regulatory submissions, and review of deliverables from external vendors. Maintain statistical sections of the Trial Master File (TMF) and ensure adherence to CDISC standards.
Innovation & Methodology: Stay updated on statistical methodologies, tools, and regulatory guidelines. Apply AI and automation tools where possible to improve efficiency.
Compliance & Documentation: Adhere to Amgen policies, SOPs, and controlled documents, supporting audits and inspections as required.
Master’s degree in Statistics, Biostatistics, or a related field with strong statistical content and 2+ years post-graduate experience in pharmaceutical or clinical research, OR
Doctoral degree in Statistics, Biostatistics, or related field with 1+ year post-graduate experience.
Competency in statistical programming using SAS or R.
Proven experience applying statistical methods in clinical trial design and analysis.
Strong communication skills in English (oral and written).
Master’s degree with 4+ years post-graduate experience or Doctorate with 2+ years.
Experience leading at least one study or project independently.
Prior experience authoring protocols, SAPs, and reviewing Clinical Study Reports (CSRs).
Familiarity with CDISC standards (SDTM, ADaM).
Exposure to AI/automation tools to drive statistical efficiency.
Strong understanding of drug development lifecycle and statistical applications across clinical programs.
Opportunity to work with a global biotechnology leader driving innovative therapies for patients worldwide.
Gain hands-on experience with cutting-edge statistical methodologies and cross-functional clinical operations.
Join a diverse, inclusive, and collaborative environment empowering innovation and professional growth.
Access to a comprehensive total rewards package, including health, financial, retirement benefits, work-life balance initiatives, and career development programs.
Equal Opportunity Statement:
Amgen is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. Reasonable accommodations are provided to individuals with disabilities to perform essential job functions.
Apply Now to join Amgen as a Senior Associate Biostatistician and advance your career in clinical research and biostatistics.
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