Senior Manager – Safety Biostatistics
Location: Hyderabad, India
Work Type: On-site
Job ID: R-238159
Category: Research / Biostatistics
Company: Amgen
Employment Type: Full-time
Job Overview
Amgen is expanding its global Biostatistics capabilities, with Amgen India playing a strategic role in integrated delivery and functional leadership. The organization is currently hiring a Senior Manager – Safety Biostatistics to provide advanced statistical expertise for safety assessment across multiple clinical studies and products.
In this role, the selected candidate will support Safety Assessment Teams and collaborate with cross-functional stakeholders to analyze aggregate safety data from ongoing clinical trials. The position requires strong analytical expertise, deep knowledge of statistical methodologies, and the ability to interpret safety data to support regulatory and clinical decision-making.
This role is ideal for experienced statisticians with a strong background in clinical research, drug development, and advanced safety data analysis within the pharmaceutical or biotechnology industry.
Key Responsibilities
Represent the Biostatistics function in multidisciplinary project meetings and collaborate with cross-functional teams to provide statistical guidance for safety assessments.
Act as an independent statistician responsible for evaluating and interpreting aggregated safety data across multiple clinical studies and products.
Lead statistical activities related to safety data analysis and provide recommendations based on statistical findings.
Contribute to the development and execution of Aggregated Safety Analysis Plans (ASAP) for clinical development programs.
Support safety assessment and reporting activities across various studies and product portfolios.
Develop and maintain standardized documentation and best practices for safety statistical methodologies.
Contribute to training materials and guidance documents related to safety statistical approaches.
Support innovative initiatives related to safety data visualization, advanced analytics, and AI-enabled analytical tools.
Ensure alignment with internal statistical policies, regulatory requirements, and global safety reporting standards.
Stay updated with advancements in statistical methodologies relevant to safety analysis and clinical trial reporting.
Required Qualifications
MSc or PhD in Statistics, Biostatistics, or a related quantitative discipline.
Demonstrated experience applying statistical methodologies in clinical development.
Proficiency in statistical programming tools such as R or SAS.
Strong analytical and problem-solving capabilities.
Ability to collaborate effectively with global cross-functional teams.
Experience Required
PhD with 2+ years of relevant experience in biostatistics, clinical trials, or pharmaceutical research,
or
Master’s degree with 4+ years of relevant experience in clinical research or statistical analysis.
Preferred Qualifications
Strong expertise in statistical design and analysis for clinical research.
Experience working within pharmaceutical, biotechnology, or medical research organizations.
Knowledge of safety data analysis methodologies, including Bayesian or advanced statistical approaches.
Experience developing or supervising the development of data visualization tools such as R/Shiny applications.
Interest in innovative analytical techniques including advanced analytics and AI-enabled safety analysis tools.
Ability to work effectively in globally distributed and cross-cultural teams.
Benefits and Compensation
Amgen offers a comprehensive rewards and benefits program designed to support employee well-being, financial security, and career development, including:
Competitive salary and performance-based annual bonus
Retirement and savings plans with company contributions
Medical, dental, and vision insurance coverage
Life and disability insurance
Flexible spending accounts
Stock-based long-term incentive programs
Generous paid time-off plans and company shutdown periods
Flexible work arrangements where applicable
Continuous learning and professional development opportunities
About Amgen
Amgen is a leading global biotechnology company focused on discovering, developing, and delivering innovative therapies for serious illnesses. With a mission to alleviate pain, restore health, and extend life, Amgen combines advanced science with cutting-edge technology to address some of the world’s most complex healthcare challenges.
Operating with a global workforce of thousands of dedicated professionals, Amgen continues to drive innovation in drug discovery, clinical development, and patient care while advancing healthcare equity worldwide.
Uttar Pradesh :
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