CrawlJobs Logo

Senior Associate - RWE Regulatory Statistical Programming

amgen.com Logo

Amgen

Location Icon

Location:
India , Hyderabad

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided

Job Description:

Amgen is seeking a dedicated Biostatistical Senior Programmer to join our Center for Observational Research (CfOR) organization, based in Hyderabad, India. This crucial role involves leading a team of senior statistical programmers who will generate Real-World Evidence (RWE) to support Amgen products throughout the drug development lifecycle. This lead programming role will collaborate with teams across multiple time zones to oversee request fulfillment, clarify requirements, track projects, resolve issues, and deliver high-quality results. The Biostatistical Programming Manager will report to a locally based Director of Biostatistical Programming. The Senior Biostatistical Programmer will be responsible for both hands-on programming as well as guiding junior programmers. Additionally, they will be responsible for manipulating large databases and generating reports to partner with epidemiologists to explore and generate RWE from real-world healthcare data assets.

Job Responsibility:

  • Support a statistical programming team conducting analyses supporting Amgen's Regulatory submission studies and projects
  • Coordinate with functional leads to prioritize workflow
  • 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
  • Review key study-related documents produced by other functions, e.g. SAPs, Data Management Plans, etc.
  • Write and/or review programming plans and analysis dataset specifications
  • Represent the programming function and participate in multidisciplinary project team meetings
  • Lead and develop technical programming and process improvement initiatives within CfOR
  • Write, test and validate department-, product- and protocol-level macros and utilities
  • Provide input to and participate in intra-departmental and CfOR meetings
  • Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings

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
  • Proficiency in SQL programming and SAS or R programming is required
  • Ability to work effectively within a large, globally distributed team

Nice to have:

  • Master’s degree in Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject
  • Experience working with real-world healthcare data (RWD) such as healthcare claims and EHR databases
  • Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
  • Team management experience
  • Global collaboration experience
  • Python programming
  • CDISC (SDTM, ADaM) knowledge
  • Agile project management
  • Knowledge of real-world data (RWD) including insurance claims databases, electronic medical records and patient registries
  • Knowledge of drug development life cycle
  • Statistics and basic epidemiology: Incidence and prevalence
  • Scientific / technical excellence
  • Oral and written communication, documentation skills
  • Leadership
  • Innovation
  • Teamwork
  • Problem solving
  • Attention to detail

Additional Information:

Job Posted:
March 20, 2026

Work Type:
On-site work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Senior Associate - RWE Regulatory Statistical Programming

Senior Associate - RWE Obesity Statistical Programming

Amgen is seeking a dedicated Senior Statistical Programmer to join our Center fo...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
Read More
Arrow Right

Senior Associate Biostatistical Programming

Amgen is seeking a Senior Associate Biostatistical Programmer to join CfOR in Ta...
Location
Location
Taiwan , Taipei
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Senior Associate Biostatistical Programming

Amgen is seeking a Senior Associate Biostatistical Programmer to join CfOR in Ta...
Location
Location
Taiwan , Taipei
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Senior Associate Biostatistical Programming

Amgen is seeking a Senior Associate Biostatistical Programmer to join CfOR in Ta...
Location
Location
Taiwan , Taipei
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Senior Manager, Evidence Generation Lead

The medical Director, evidence generation is responsible for supporting strategi...
Location
Location
Belgium , Mechelen
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum of 7+ years of experience in evidence generation, clinical development, HEOR, or a related field, with at least 5 years of experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research
  • Proven track record of developing and implementing integrated evidence generation plans in the pharmaceutical or biotechnology industry
  • Experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication
  • Solid understanding of the cross functional drug development lifecycle and processes (Business Development, clinical trial design, conduct, & endpoint selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)
  • Demonstrated expertise and experience working with methods for evidence generation using primary and secondary data sources, knowledge of common issues and challenges of implementation, and track-record of successful publications
  • Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
  • Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
  • Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs
  • Ability to work successfully in a matrix and quick paced environment
  • Ability to multitask priorities to align with program objectives
Job Responsibility
Job Responsibility
  • Collaborate with cross-functional colleagues to Lead the development and execution of Medical evidence generation strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources ensuring alignment with corporate goals, regional needs, and therapeutic priorities
  • Oversee the Design and implementation of Integrated Evidence Generation Plans (IEGPs) that incorporate clinical, real-world, and economic data to support product positioning and value demonstration
  • Scope RWE studies (Regional/National/Academic/Patient/Vendor), selection of new or existing academic (can include: ISR/lIS/NIS)/non-governmental registries (retrospective/prospective), management across various phases from start up, maintenance to final deliverables
  • Translate (early) trial efficacy to real-world comparative effectiveness as part of early and late phase study planning, identification of subpopulations, and for potential risk-sharing purposes
  • Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits and/or risks potentially associated with Alfasigma products
  • Project management oversight – ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and where appropriate contracting with partner organizations
  • keep abreast on new data and developments in the field, key publications of interest, research methodologies and regulatory standards across the EU and New Markets regions and proactively address HOR strategy changes in collaboration with global and regional teams in anticipation of any trends
  • Review and provide relevant RWE/HOR inputs to statistical analysis plans and analysis outputs
  • Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
  • Establish metrics to evaluate the effectiveness and impact of evidence generation activities on corporate and product-specific objectives
What we offer
What we offer
  • We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development
Read More
Arrow Right
New

Program Security Representative (PSR) III

The Air Force (AF) Special Access Program (SAP) Security Support Services (SSS) ...
Location
Location
United States , Washington, DC
Salary
Salary:
Not provided
gTANGIBLE Corporation
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in a related area and 10-12 years of related experience OR Associates Degree in a related area and 12-14 years of related experience OR 14-16 years of equivalent experience without a degree
  • Security Fundamentals Professional Certification (SFPC) counts towards 3 years of experience
  • Special Program Security Certification (SPSC) counts towards 5 years of experience
  • Maximum equivalent experience for Security Professional Education Development (SPED) Certifications is no more than 5 years
  • Minimum of two years of SAP experience required
  • Prior active duty in the U.S. Air Force a plus
  • Top Secret/SCI, SAP Information eligible, consent for Counterintelligence polygraph
Job Responsibility
Job Responsibility
  • Ensure strict adherence to the provisions of the National Industrial Security Program Operating Manual, its Supplement, the DoD Overprint, Director of Central Intelligence Directives, Intelligence Community Directive, and SAP policy
  • Assist in developing and executing approved policies and procedures for safeguarding SAP, SCI and collateral data in support of US military operations
  • Provide day-to-day security support that includes continuous assessment of procedures to identify shortfalls and provide appropriate recommendations for revising and improving security policies, procedures, and systems
  • Identify vulnerabilities, threats, and risks to test, training, and operational activities
  • Assist in developing, implementing, and training the Operations Security program
  • Assist in providing contractor and subordinate facility assistance and oversight
  • Brief all levels of personnel, both in the government and senior civilian services, on a variety of security related topics
  • Conduct and document SAP facility compliance reviews, follow-on facility reviews, and facility close-outs
  • Monitor, report and track all corrective actions resulting from compliance reviews
  • Ensure timely notification of pertinent security matters to program technical and management staff
  • Fulltime
Read More
Arrow Right
New

B&F Server

B&F Server role at W London's Perception Bar & W Lounge in Soho. Part of a team ...
Location
Location
United Kingdom , London
Salary
Salary:
Not provided
https://www.marriott.com Logo
Marriott Bonvoy
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Eligibility to work and live in the UK (documented evidence required)
  • Passionate, playful, audacious, and polished personality
  • Ability to work in a fast-paced environment under pressure with loud music
  • Flexibility to work with other departments
  • Strong communication skills with team and other departments
  • Expert knowledge of B&F, menus, hotel facilities, and possibilities
  • Ability to follow service standards and operating procedures
  • Commitment to putting guests at the center of everything
Job Responsibility
Job Responsibility
  • Responsible for the daily operations at The Perception Bar
  • Making suggestions for cocktails and food pairings
  • Following service standards and operating procedures
  • Providing Whatever/Whenever service and personalizing it for guests
  • Maintaining a clean environment
  • Cooperating with other departments
  • Communicating with team and other departments
  • Creating unforgettable experiences for guests
What we offer
What we offer
  • Complimentary Meals
  • Monthly Service Charge
  • Learning & Development
  • Apprenticeships
  • Holiday Entitlement (28 days including public holidays)
  • Refer a Friend Scheme (£250)
  • Company Pension Scheme
  • Recognition & Celebration
  • High Street Discounts
  • Monthly Associate Events
  • Fulltime
Read More
Arrow Right
New

Evening Commercial cleaner

This position is responsible for creating cleaner and healthier environments for...
Location
Location
United States , Lowell
Salary
Salary:
14.00 USD / Hour
servicemasterbyprince.com Logo
ServiceMaster by Prince
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Constant (up to 100%) standing, walking, pushing, kneeling, twisting, reaching
  • Must be able to lift and/or carry up to 25lbs.
  • Strong work ethic and willingness to learn
  • Ability to be flexible and work at a fast pace in a multi-tasked job
  • Dependable and on time
  • Treat all co-workers and customers with courtesy and respect
Job Responsibility
Job Responsibility
  • Perform all cleaning duties for facilities using provided ServiceMaster products, tools and procedures
  • Vacuuming, mopping, trash removal, restroom cleaning, windows, dusting
  • Maintain inventory of supplies and equipment
What we offer
What we offer
  • 401(k)
  • Free uniforms
  • Training & development
  • Competitive Pay
  • Part time Flexible Schedules
  • Career Path Opportunities
  • Paid Training
  • Paid training
  • Excellent work/life balance
  • Opportunities for advancement and a career path
  • Parttime
Read More
Arrow Right