Biostatistics Senior Associate (Study Statistician) – Amgen
Location
Hyderabad, India
Job Type
Full-time (On-site)
Department
Clinical – Global Biostatistics
Experience Required
4+ years of post-graduate experience as a Statistician in Pharmaceutical, Biotechnology, Clinical Research, or Medical Research environments with a Master’s degree.
2+ years of post-graduate experience with a Doctoral degree in Statistics/Biostatistics.
Experience applying statistical methodologies in clinical trials is required.
Estimated Salary Package (Market Standard)
₹18 – ₹35 LPA (approx.), depending on statistical expertise, clinical trial experience, programming skills, and interview performance.
Job Overview
The Biostatistics Senior Associate (Study Statistician) provides statistical expertise across clinical development programs by supporting study design, statistical analysis, clinical trial reporting, and regulatory submissions. The role involves authoring statistical documents, performing clinical trial analyses, ensuring data quality, and collaborating with cross-functional teams to deliver scientifically rigorous and compliant study outputs.
Key Responsibilities
Statistical Study Support
Provide statistical input throughout the clinical trial lifecycle.
Support study design, analysis planning, and interpretation of clinical data.
Conduct statistical analyses for:
Primary endpoints
Secondary endpoints
Exploratory analyses
Dose-level evaluations
Ensure statistical methods are scientifically appropriate and aligned with regulatory expectations.
Statistical Documentation
Author and review key statistical documents, including:
Statistical Analysis Plans (SAPs)
Table, Figure, and Listing (TFL) shells
Randomization specifications
Submission data file specifications
Statistical sections of clinical documents
Support preparation of clinical study reports and regulatory submission documents.
Clinical Data Analysis & Quality Control
Perform statistical programming and data analysis using SAS or R.
Conduct quality control (QC) reviews of:
Clinical datasets
Statistical outputs
Analysis results
Ensure compliance with CDISC standards and data quality requirements.
Collaborate with Statistical Programmers for timely delivery of study outputs.
Cross-Functional Collaboration
Participate in Clinical Study Team (CST) meetings.
Provide statistical guidance to clinical, data management, and programming teams.
Collaborate with external suppliers and review deliverable quality.
Support scientific publications and clinical research outputs.
Regulatory & Compliance Activities
Maintain statistical documentation within the Trial Master File (TMF).
Support audits and inspection readiness activities.
Follow Amgen SOPs, policies, and controlled documents.
Stay updated with regulatory guidelines and statistical methodologies.
Educational Qualification
Master's degree in:
Statistics
Biostatistics
Mathematics
Or related fields with strong statistical content
OR
Doctoral degree (PhD) in Statistics, Biostatistics, or related quantitative discipline.
Required Skills
Strong understanding of statistical methods used in clinical trials.
Experience analyzing clinical trial data.
Proficiency in statistical programming:
SAS
R
Knowledge of clinical development processes and drug development lifecycle.
Experience preparing statistical documentation.
Ability to interpret and communicate statistical findings.
Strong written and verbal English communication skills.
Ability to collaborate effectively with global teams.
Preferred Qualifications
Master's degree with 6+ years of experience or Doctorate with 4+ years of experience.
Experience independently leading at least one clinical study or project.
Experience authoring:
Protocols
Statistical Analysis Plans (SAPs)
Clinical Study Reports (CSRs)
Familiarity with CDISC standards:
SDTM
ADaM
Experience using AI and automation tools for statistical efficiency.
Strong understanding of statistical applications across the clinical development lifecycle.
Work Environment
On-site role based in Hyderabad.
Collaboration with global Biostatistics, Clinical Development, Data Management, and Statistical Programming teams.
Opportunity to support innovative biotechnology programs and global clinical trials.
Who Should Apply
Study Statisticians, Clinical Statisticians, Biostatisticians, and Statistical Analysts with pharmaceutical or clinical research experience.
Professionals with strong SAS/R skills and clinical trial expertise looking to advance in Clinical Biostatistics, Drug Development, Regulatory Statistics, and Global Research Programs.
Uttar Pradesh :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Mexico |northeastern :
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Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
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Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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