Biostatistical Programming Manager Job at Amgen (Hyderabad)

Biostatistical Programming Manager

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.
Thorough understanding of clinical trial processes, from data collection to analysis reporting
Proven record of superior statistical programming and problem-solving skills within clinical development environment
Prior experience and ability to lead and manage statistical programmers in successful and timely completion of all programming related activities (including preparing data and programming specifications) for a study end-to-end
In-depth knowledge on latest CDISC SDTM, ADaM, and Define standards along with strong ability to implement all aspects of those standards
Advanced analysis and reporting skills in SAS, including SAS/STAT packages, among others
Experience in data quality and compliance check tools
Excellent project management skills and ability to lead multiple projects effectively
Excellent oral and written English communication skills
Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners

Job Responsibility

Lead one, or more than one, study/project end to end and assume all the responsibilities of Study Lead Programmer
Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables
Lead and manage specific programming tasks (e.g., all programming related activities of an integrated analysis that involves multiple studies for regulatory submissions) assigned to the team
Participate in establishing the programming scope for a deliverable with the statisticians and the study team
Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project
Create and maintain programming related specifications (e.g., SDTM and ADaM) for the studies/projects
Represent GSP at the Clinical Study Team (CST)
Attend meetings for, and provide programming input into, cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review, data quality check specifications
Initiate cross-functional team meetings as necessary
Perform significant hands-on statistical programming, particularly for those most challenging deliverables

Fulltime

Biostatistical Programming Manager

This role is part of the centrally managed Quality and Quick Response (QQR) Prog...

Location

United States

Salary:

130000.00 - 140000.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of statistical programming experience OR Bachelor's degree and 4 years of statistical programming experience OR Associate's degree and 8 years of statistical programming experience OR High school diploma / GED and 10 years of statistical programming experience

Job Responsibility

Provide rapid response statistical programming support for urgent internal and external requests
Serve as a lead programmer for studies and projects, such as Data Access Plan (DAP) activities, unblinding efforts, and special projects
Deliver hands-on programming support for SDTM, ADaM, Tables, Listings, and Figures (TFLs), and other study and regulatory submission deliverables as needed
Oversee the execution and quality of projects managed by our FSP partners per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP)
Ensure that FSP and in-house programming deliverables meet quality, compliance, timeline, and productivity expectations
Mitigate at-risk projects by providing technical expertise, programming support, and operational guidance
Contribute to training material development and delivery to internal teams and FSP partners
Provide guidance and technical consultancy to study programming team on Amgen processes, tools, and utilities
Lead/contribute to GSP continuous improvement iniatives and support cross-functional initiatives including inspection readiness, process improvement, innovation, and training activities
Contribute to programming team performance metrics development, data collection, and reporting

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
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
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Biostatistical Programming Manager

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 6 years of statistical programming experience in clinical development environment
Thorough understanding of clinical trial processes, from data collection to analysis reporting
Proven record of superior statistical programming and problem-solving skills within clinical development environment
Prior experience and ability to lead and manage statistical programmers in successful and timely completion of all programming related activities (including preparing data and programming specifications) for a study end-to-end
In-depth knowledge on latest CDISC SDTM, ADaM, and Define standards along with strong ability to implement all aspects of those standards
Advanced analysis and reporting skills in SAS, including SAS/STAT packages, among others
Experience in data quality and compliance check tools
Excellent project management skills and ability to lead multiple projects effectively
Excellent oral and written English communication skills
Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners

Job Responsibility

Lead one, or more than one, study/project end to end and assume all the responsibilities of Study Lead Programmer
Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables
Lead and manage specific programming tasks (e.g., all programming related activities of an integrated analysis that involves multiple studies for regulatory submissions) assigned to the team
Participate in establishing the programming scope for a deliverable with the statisticians and the study team
Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project
Create and maintain programming related specifications (e.g., SDTM and ADaM) for the studies/projects
Represent GSP at the Clinical Study Team (CST)
Attend meetings for, and provide programming input into, cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review, data quality check specifications
Initiate cross-functional team meetings as necessary
Perform significant hands-on statistical programming, particularly for those most challenging deliverables

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 Manager

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 6 years of statistical programming experience in clinical development environment
Thorough understanding of clinical trial processes, from data collection to analysis reporting
Proven record of superior statistical programming and problem-solving skills within clinical development environment
Prior experience and ability to lead and manage statistical programmers in successful and timely completion of all programming related activities for a study end-to-end
In-depth knowledge on latest CDISC SDTM, ADaM, and Define standards along with strong ability to implement all aspects of those standards
Advanced analysis and reporting skills in SAS, including SAS/STAT packages
Experience in data quality and compliance check tools
Excellent project management skills and ability to lead multiple projects effectively
Excellent oral and written English communication skills
Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners

Job Responsibility

Lead one, or more than one, study/project end to end and assume all the responsibilities of Study Lead Programmer
Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables
Lead and manage specific programming tasks assigned to the team
Participate in establishing the programming scope for a deliverable with the statisticians and the study team
Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project
Create and maintain programming related specifications for the studies/projects
Represent GSP at the Clinical Study Team
Attend meetings for, and provide programming input into, cross-functional study start-up activities
Initiate cross-functional team meetings as necessary
Perform significant hands-on statistical programming, particularly for those most challenging deliverables

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 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

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

Biostatistical Programming Senior Manager

In this vital role you will provide operational and technical leadership for Rea...

Location

United Kingdom , Uxbridge; Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Relevant statistical programming experience within life sciences, clinical development, or observational research
Experience leading people, projects, programs, or resource allocation activities within a programming environment
Experience working with real-world healthcare data, including healthcare claims and EHR databases
Strong programming expertise in SAS and SQL
Knowledge of observational research methods, drug development, and epidemiology principles
Strong communication, collaboration, and stakeholder management skills
Demonstrated leadership, problem-solving ability, innovation, and attention to detail
Experience with R and/or Python is preferred but not mandatory

Job Responsibility

Provide operational and technical leadership for Real-World Evidence (RWE) biostatistical programming within the Centre for Observational Research (CfOR)
Lead and develop programming teams, partnering closely with epidemiologists and cross-functional stakeholders across multiple time zones to deliver high-quality RWE from large healthcare data sources, including electronic health records (EHR) and healthcare claims databases
Oversee project delivery, resource planning, technical excellence, and compliance with departmental standards and processes to support regulatory, publication, and enterprise objectives
Leading and developing programming staff, including mentoring, workload planning, and performance oversight
Partnering with epidemiologists, RWE scientists, and programming leads to generate robust real-world evidence from healthcare data assets
Providing technical leadership and guidance in statistical programming methods, standards, and best practices
Managing programming activities, timelines, deliverables, and resource allocation across multiple projects and priorities
Ensuring programming activities comply with departmental standards, SOPs, quality expectations, and regulatory requirements
Authoring, reviewing, and approving programming plans, analysis dataset specifications, macros, and other key study documentation
Contributing to the development, validation, and execution of analysis datasets and outputs supporting regulatory submissions, publications, and scientific communications

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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