Biostatistics Senior Manager Job at Amgen

Senior Manager Biostatistics (Study Lead Statistician)

How might you defy imagination? If you feel like you're part of something bigger...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Master's degree in Statistics/Biostatistics or related subject with high statistical content and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Bachelor's degree in Statistics/Biostatistics or related subject with high statistical content and at least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Job Responsibility

Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs
Plan and execute statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
Implement, manage and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis
Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen's statistical policies, procedures and strategies
Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
Serve as the GBS lead on the Clinical Study Team leadership team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study
Provide statistical consultancy, training, and advice within Amgen

What we offer

Vast opportunities to learn and develop within our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Senior Manager Biostatistics

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN)...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Or Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Job Responsibility

Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs.
Plan and execute statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
Implement, manage and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis.
Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies.
Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
Serve as the GBS lead on the Clinical Study Team leadership team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study
Provide statistical consultancy, training, and advice within Amgen

What we offer

Vast opportunities to learn and develop within our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Senior Manager-Safety Biostatistics

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN)...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

MSc or PhD in Statistics, Biostatistics, or related field
Doctorate degree and 2 years of experience OR Master’s degree and 4 years of experience
Proven ability to apply statistical methods in clinical development
Proficient in an analytical application (e.g., R or SAS)

Job Responsibility

Represent the Biostatistics function in multidisciplinary project team meetings and collaborate with cross-functional partners to provide sound statistical guidance for safety assessment
Act as an independent statistician, providing objective statistical expertise for the assessment and interpretation of aggregate safety data across multiple studies/products and formulating sound conclusions and recommendations
Provide safety statistics expertise on aggregated safety analysis plans (ASAP) and safety assessment and reporting activities across multiple studies/products
Develop, maintain, and set standards for associated controlled process documents, including defining best practices for aggregate safety statistical methodologies, and support the development and application of related training and guidance materials across programs
Support innovative projects related to technical enhancements for safety assessment, involving data visualizations, decision-making toolkits, and appropriate advanced analytics, including AI integration
Maintain familiarity with Amgen statistical policies, strategies, and regulatory guidance, and stay abreast of developments in statistical methods relevant to safety assessment and reporting

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Senior Manager, Health Economics & Value - Enterprise Corporate Accounts

As the Senior Manager, Health Economics & Value - Enterprise Corporate Accounts,...

Location

United States , Batesville

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree in health economics, health policy, epidemiology, biostatistics, pharmacy, or a related discipline (Master's, PhD, PharmD) or equivalent experience preferred
5+ years of experience in HEOR, health economics, market access, or reimbursement strategy within medical devices, digital health, or hospital solutions preferred
Demonstrated experience developing economic models (ROI, budget impact, cost-effectiveness) and translating them into customer-ready tools
Strong understanding of U.S. healthcare provider economics, including VAC processes, quality metrics, and inpatient/outpatient dynamics
Experience with real-world evidence generation or outcomes measurement in a hospital setting
Experience partnering directly with health systems on pilots, quality improvement initiatives, or outcomes-based programs
Ability to tailor value stories to clinical, operational, and financial audiences, with strong provider economic fluency
Proven ability to lead programs, drive cross-functional alignment, and balance analytical rigor with real-world timelines and data constraints

Job Responsibility

Develop and implement health system value programs that define measurable clinical, operational, and financial outcomes tied to Baxter product adoption
Translate customer priorities into jointly agreed value demonstration activities, including implementation, analysis, and performance measurement
Lead cross-functional teams to shape customer-facing deliverables and ensure alignment across commercial, clinical, and operational stakeholders
Design and execute economic analyses credible to value analysis committees (VAC), clinical leaders, and purchasing stakeholders
Build and refine ROI tools and economic models across multiple care pathways, ensuring methodological rigor and transparency
Partner with internal and external stakeholders to ensure models reflect how health systems evaluate value (cost, labor, productivity, capacity, revenue)
Collaborate with marketing, commercial, and R&D teams to prioritize evidence needs and support strategic portfolio decisions
Support reimbursement strategy across the portfolio, including coding, coverage, payment considerations, and policy monitoring

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Centralized Statistical Monitoring, Senior Manager

In this vital role you will provide statistical, technical, operational, and bus...

Location

United States

Salary:

154104.15 - 208493.85 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 4 years of relevant experience
Master's degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 8 years of relevant experience
Bachelor's degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 10 years of relevant experience

Job Responsibility

Serve as the business owner for Amgen's CSM analysis system, signal framework, and analytical workflows
Provide leadership for the CSM Statistics team and accountability for statistical deliverables supporting the CSM capability
Partner with the Head of CSM / CfDA Safety to shape and execute the strategy, roadmap, and operating model for CSM
Advance CSM methodology within the broader RBQM framework to support Quality by Design, data quality, data integrity, and study quality oversight
Prioritize CSM system enhancements, signal development, automation opportunities, and related RBQM analytical needs, including QTL approaches where aligned with CSM scope and portfolio priorities
Support governance, documentation, inspection readiness, and long-term sustainability of the CSM capability
Serve as a senior point of contact for CSM-related questions, escalations, and study team support

What we offer

Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
discretionary annual bonus program
stock-based long-term incentives
award-winning time-off plans
flexible work models where possible

Fulltime

Senior Manager, Biostatistical Programming

Amgen is expanding its Global Statistical Programming (GSP) capabilities, with A...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 8 years of statistical programming experience in clinical development environment
Strong technical, communication, and leadership skills
Ability to lead and manage programmers in successful and timely completion of all programming activities for a study or multiple studies from end to end
Experience developing a successful offshore statistical programming team
Flexibility and desire to work across different time-zones
Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, Graph, SQL, etc.)
Prior regulatory submission experience for drug approval
Thorough understanding and experience with data quality and compliance checks
Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans)
Experience working effectively in a globally dispersed team environment with cross-cultural partners

Job Responsibility

Accountable and responsible for ensuring successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for a product, or group of Amgen products, being supported by the offshore programming team
Work with GPL to ensure successful implementation of programming strategies, such as functional standards and industry requirements for the assigned product globally
Plan and monitor progress of projects and address issues accordingly
Provide GSP product level input to developing and managing resource plans and budgets for GSP
Efficiently and effectively monitor and utilize assigned staff at product level according to priorities
Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
Assist in study and system audits and inspections by internal and external bodies
Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally
Provide hands-on support to the assigned product areas as required
Provide coaching and mentoring to local programming staff

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Biostatistical Programming Senior Manager

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States

Salary:

157896.85 - 213625.15 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years Statistical Programming experience
Master’s degree and 6 years Statistical Programming experience
Bachelor’s degree and 8 years Statistical Programming experience
Associate’s degree and 10 years Statistical Programming experience
High school diploma and 12 years Statistical Programming experience

Job Responsibility

Maintain and develop re-usable software utilities for GBS and GSP
Provide technical leadership and guidance for programming teams
Oversee FSP programming team
Partner with IS to maintain and enhance GSP systems
Coordinate and collaborate with CfDA on design and implementation of statistical analysis and reporting applications
Develop and maintain departmental software utilities to support the analysis and reporting of clinical trials data
Adhere to functional standards, processes and methods across all projects
Create, maintain, and review key SDLC documents -Requirements, Operational Qualification, Installation Qualification, and Design documents
Create, maintain, and review end-user documentation (e.g., user guides, training materials)
Participate in establishing the programming scope, timeline and quality for deliverables with stakeholders

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Senior Manager, Biostatistical Programming

Amgen is expanding its Global Statistical Programming (GSP) capabilities, with A...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 8 years of statistical programming experience in clinical development environment
Strong technical, communication, and leadership skills
Ability to lead and manage programmers in successful and timely completion of all programming activities for a study or multiple studies from end to end
Experience developing a successful offshore statistical programming team
Flexibility and desire to work across different time-zones
Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, Graph, SQL, etc.)
Prior regulatory submission experience for drug approval
Thorough understanding and experience with data quality and compliance checks
Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans)
Experience working effectively in a globally dispersed team environment with cross-cultural partners

Job Responsibility

Accountable and responsible for ensuring successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for a product, or group of Amgen products, being supported by the offshore programming team
Work with GPL to ensure successful implementation of programming strategies, such as functional standards and industry requirements for the assigned product globally
Plan and monitor progress of projects and address issues accordingly
Provide GSP product level input to developing and managing resource plans and budgets for GSP
Efficiently and effectively monitor and utilize assigned staff at product level according to priorities
Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
Assist in study and system audits and inspections by internal and external bodies
Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally
Provide hands-on support to the assigned product areas as required
Provide coaching and mentoring to local programming staff

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

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Biostatistics Senior Manager

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