Manager - RWE Regulatory Statistical Programming Job at Amgen (Hyderabad)

Biostatistical Programming Senior Manager

In this vital role you will be responsible for developing and leading teams in t...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
Master’s degree and 8 to 10 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
Bachelor’s degree and 10 to 14 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
Diploma and 14 to 18 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
At least eight (8) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in a statistical programming team working with real-world healthcare data (RWD)
Experience leading a statistical programming team within RWE
RWE generation in pharmaceutical or related research industries, or statistical programming for clinical trials
Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model
Department or multi-team management

Job Responsibility

Provide technical solutions to programming problems within the Centre for Observational Research (CfOR)
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming function and participate in multidisciplinary project team meetings
Project manage programming activities, according to agreed resource and timeline plans
Ensure programming activities adhere to departmental standards and SOPs
Write and/or review and approve programming plans
Write and/or review and approve analysis dataset specifications
Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
Write, test, validate and execute department-, product- and protocol-level macros and utilities

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

New

Associate - RWE Regulatory Statistical Programming

Amgen is seeking a dedicated Associate Biostatistical Programmer to join our Cen...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
At least two (2) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
Proficiency in SAS and SQL programming
Experience with R and Python is preferred
Scientific and technical excellence
Exceptional oral and written communication skills
Problem-solving abilities
Meticulous attention to detail
Ability to work effectively within a large, globally distributed team

Job Responsibility

Support a statistical programming team conducting analyses supporting Amgen's Regulatory submission studies and projects
Provide technical solutions to programming problems within CfOR
Ensure the analysis and presentation of biomedical data is accurate and complete
Adhere to Amgen policies, SOPs and other controlled documents
Write, test, and validate programs in SAS, Databricks, or R to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications, and other internal and external communications
Complete programming activities, according to agreed resource and timeline plans
Create key study-related documents produced by other functions, e.g. SAPs, Data Management Plans, etc.
Write programming plans and analysis dataset specifications
Develop technical programming and process improvement initiatives within CfOR
Write, test and validate department-, product- and protocol-level macros and utilities

New

Senior Associate - RWE Obesity Statistical Programming

Amgen is seeking a dedicated Senior Statistical Programmer to join our Center fo...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
At least four (4) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
Experience in SQL, and statistical programming using SAS or R

Job Responsibility

Write, test and validate software programs in Unix and Databricks to produce analysis datasets and presentation output such as tables and figures, to be included in reports for submission to regulatory agencies, publications and other communications
Provide technical solutions to programming problems within CfOR
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming function and participate in multidisciplinary project team meetings
Manage all programming activities, according to agreed resource and timeline plans
Ensure all programming activities on the project adhere to departmental standards
Write and/or review and approve all programming plans
Write and/or review and approve analysis dataset specifications
Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
Write, test, validate and execute department-, product- and protocol-level macros and utilities

Senior Associate Biostatistical Programming

Amgen is seeking a Senior Associate Biostatistical Programmer to join CfOR in Ta...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Business Analytics, or related field OR
Bachelor’s degree and 2 years of directly related experience OR
Associate’s degree and/or 4 years of directly related experience OR
High school diploma / GED and 6 years of directly related experience
At least four (4) years of relevant statistical programming experience in a clinical development or life sciences setting, including postgraduate research experience
Experience in SQL, and statistical programming using SAS and R
Track record establishing analysis standards, QC/QA processes, and controlled change management.
Experience or willingness to learn the process of delivering regulatory-grade analyses and submission-ready deliverables
Foundational understanding of medical statistics (e.g., study design, hypothesis testing, confidence intervals).
Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials

Job Responsibility

Develop, test, validate, and execute programming code and macros that generate analysis datasets and tables, listings, and figures to support decision making in drug development
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming team and collaborate with peers in clinical and epidemiology functions
Manage programming activities and provide technical solutions to programming issues
Ensure programming activities adhere to departmental standards and SOPs as well as local compliance and regulatory standards
Write and review programming plans and dataset specifications
Review key study-related documents including but not limited to statistical analysis plans (SAPs) and data management plans (DMPs)
Participate in the development of departmental policies and controlled documents
Participate in the recruitment of programming staff
Actively participate in external professional organizations, conferences, and meetings

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

Senior Associate Biostatistical Programming

Amgen is seeking a Senior Associate Biostatistical Programmer to join CfOR in Ta...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Business Analytics, or related field OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and/or 4 years of directly related experience OR High school diploma / GED and 6 years of directly related experience
At least four (4) years of relevant statistical programming experience in a clinical development or life sciences setting, including postgraduate research experience
Experience in SQL, and statistical programming using SAS and R
Track record establishing analysis standards, QC/QA processes, and controlled change management
Experience or willingness to learn the process of delivering regulatory-grade analyses and submission-ready deliverables
Foundational understanding of medical statistics (e.g., study design, hypothesis testing, confidence intervals)
Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
Strong individual contributor, proficient in developing analysis datasets, identifying data anomalies, and ensuring program accuracy
Motivated to learn how to work with real-world healthcare data (RWD) such as MDV and DeSC
Experience with Git-based version control and maintaining analysis documentation

Job Responsibility

Develop, test, validate, and execute programming code and macros that generate analysis datasets and tables, listings, and figures to support decision making in drug development
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming team and collaborate with peers in clinical and epidemiology functions
Manage programming activities and provide technical solutions to programming issues
Ensure programming activities adhere to departmental standards and SOPs as well as local compliance and regulatory standards
Write and review programming plans and dataset specifications
Review key study-related documents including but not limited to statistical analysis plans (SAPs) and data management plans (DMPs)
Participate in the development of departmental policies and controlled documents
Participate in the recruitment of programming staff
Actively participate in external professional organizations, conferences, and meetings

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

Senior Associate Biostatistical Programming

Amgen is seeking a Senior Associate Biostatistical Programmer to join CfOR in Ta...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Business Analytics, or related field OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and/or 4 years of directly related experience OR High school diploma / GED and 6 years of directly related experience
At least four (4) years of relevant statistical programming experience in a clinical development or life sciences setting, including postgraduate research experience
Experience in SQL, and statistical programming using SAS and R
Track record establishing analysis standards, QC/QA processes, and controlled change management
Experience or willingness to learn the process of delivering regulatory-grade analyses and submission-ready deliverables
Foundational understanding of medical statistics (e.g., study design, hypothesis testing, confidence intervals)
Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
Strong individual contributor, proficient in developing analysis datasets, identifying data anomalies, and ensuring program accuracy
Motivated to learn how to work with real-world healthcare data (RWD) such as MDV and DeSC
Experience with Git-based version control and maintaining analysis documentation

Job Responsibility

Develop, test, validate, and execute programming code and macros that generate analysis datasets and tables, listings, and figures to support decision making in drug development
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming team and collaborate with peers in clinical and epidemiology functions
Manage programming activities and provide technical solutions to programming issues
Ensure programming activities adhere to departmental standards and SOPs as well as local compliance and regulatory standards
Write and review programming plans and dataset specifications
Review key study-related documents including but not limited to statistical analysis plans (SAPs) and data management plans (DMPs)
Participate in the development of departmental policies and controlled documents
Participate in the recruitment of programming staff
Actively participate in external professional organizations, conferences, and meetings

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

New

Associate RWE Oncology Statistical Programming

Amgen is seeking a dedicated Associate Biostatistical Programmer to join our Cen...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
At least two (2) years of relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
Experience in statistical programming using SAS and SQL

Job Responsibility

Write, test and validate software programs in Unix and Databricks to produce analysis datasets and presentation output such as tables and figures, to be included in reports for submission to regulatory agencies, publications and other communications
Provide technical solutions to programming problems within CfOR
Lead and develop technical programming and process improvement initiatives within CfOR
Represent the programming function and participate in multidisciplinary project team meetings
Manage all programming activities, according to agreed resource and timeline plans
Ensure all programming activities on the project adhere to departmental standards
Write and/or review and approve all programming plans
Write and/or review and approve analysis dataset specifications
Write, test, validate and execute department-, product- and protocol-level macros and utilities
Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings

Partner Research & Success Manager

Truveta is the world’s first health provider led data platform with a vision of ...

Location

United States , Seattle

Salary:

115000.00 - 130000.00 USD / Year

Truveta

Expiration Date

Until further notice

Requirements

4+ years of experience working in a field which developed exposure to and understanding of real-world data (RWD), real world evidence (RWE), public health research, or regulatory submissions
2+ years of experience in customer success, account management, or consulting, ideally with a focus on life science customers
Experience with statistical analysis and programming languages such as R, SQL, and Python
Understanding of the business value of Real World Data (RWD) to pharmaceutical and medical device industries
Strong project management skills, great written and oral communication, and a willingness to ask questions
Ability to work independently, take ownership of deliverables, navigate ambiguity and juggle multiple projects simultaneously
Proactive mindset that can operationalize implementable solutions and quickly solve problems
Superb attention to detail and ability to complete tasks in a timely manner with a high degree of accuracy
Understanding of scientific and/or technical information and ability to communicate to less familiar audiences
Maintains a high degree of professionalism and enthusiasm

Job Responsibility

Support a portfolio of Truveta customer relationships across a range of research projects. This includes new customer onboarding, ongoing customer education and training, conducting simple and complex data queries, and responding to ad-hoc customer requests
Collaborate with the Partner Research and Success team in meeting internal and external demands by providing project management support. Develop targeted action plans, track progress towards key deliverables, identify any risks, etc.
Clearly summarize the findings of customer analyses in Truveta branded reports, slide decks, and papers
Build operational efficiency. Collaborate with the broader team to maintain and improve internal team processes, standards, and workflows
Contribute to client growth. Facilitate programing that ensures customers receive maximum value from their engagement with Truveta
Proactively identify and raise potential workflow issues
develop and provide recommendations for resolution
Maintain internal visibility at Truveta as a customer advocate and voice
Occasional but mandatory domestic travel (~5x/yr)
The ability to attend virtual meetings that align across US time zones

What we offer

Interesting and meaningful work for every career stage
Great benefits package
Comprehensive benefits with strong medical, dental and vision insurance plans
401K plan
Professional development & training opportunities for continuous learning
Work/life autonomy via flexible work hours and flexible paid time off
Generous parental leave
Regular team activities (virtual and in-person)

Fulltime

Manager - RWE Regulatory Statistical Programming

Amgen

Location:
India , Hyderabad

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
March 05, 2026

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