Manager - RWE Innovation Programming Job at Amgen (Hyderabad)

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

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

Senior Director, Respiratory Innovation, VID Global Epidemiology & RWE

The Senior Director, Respiratory Innovation, Vaccines and Infectious Disease, Gl...

Location

United States; Belgium; United Kingdom; Netherlands , Collegeville, Pennsylvania; Amsterdam, Netherlands; Wavre, Belgium; Rockville, Maryland; London, United Kingdom

Salary:

224400.00 - 374000.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

PhD, DrPH, MD, or other doctoral degree in epidemiology, public health, biostatistics, or a closely related quantitative discipline
At least 8 years of experience conducting pharmacoepidemiology or real-world evidence (RWE) studies
Experience designing and conducting observational studies (e.g., post-approval studies, real-world evidence generation)
Experience leading epidemiology programs supporting clinical development and/or regulatory decision-making
Experience within the pharmaceutical, biotechnology, vaccine, or related research environment
Experience building and managing or leading teams of scientific or technical professionals
Experience authoring or contributing to scientific publications or regulatory documents

Job Responsibility

Provide strategic leadership in epidemiology and real-world evidence across multiple programs and assets
Lead and develop a team of epidemiologists, ensuring high-quality scientific output and delivery
Oversee the design and execution of epidemiologic studies, including observational and post-approval studies
Partner with cross-functional teams (e.g., clinical sciences, safety, regulatory) to support research and development programs and evidence generation
Contribute to governance and strategic decisions at an above-asset level
Oversee scientific dissemination, including publications, conference presentations, and regulatory documents
Build and maintain external collaborations with academic institutions, consortia, and research organizations

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays, vacation
Paid caregiver/parental and medical leave

Fulltime

Associate Director, Epidemiology (Global Health)

Location

United States , Collegeville

Salary:

129000.00 - 179000.00 CAD / Year

GSK

Expiration Date

Until further notice

Requirements

Master’s degree in Epidemiology, Public Health, Biostatistics, or a related quantitative discipline
Epidemiological experience and ability to influence key internal (matrix leaders) and external (e.g. regulators) stakeholders
Experience applying epidemiologic methods in pharmacoepidemiology, clinical development, or outcomes research
Experience designing and delivering observational and database studies, including protocol development and analysis oversight
Experience working in a matrix environment and influencing multidisciplinary teams
Experience providing the delivery of increasingly complex epidemiological studies, including regulatory requirements
Experience applying epidemiology methods and study design knowledge in execution of their work (e.g. post-approval studies)
Experience working with external regulatory requirements and scientific landscape around RWE

Job Responsibility

Accountable for the epidemiology program for at least one asset or disease area, including proposing and negotiating program content and budget with matrix leaders
Provide expert epidemiological insights to asset matrix teams (e.g., Clinical Development Team, Safety Review Team, Medicine/Vaccine Development Team)
Lead complex epidemiological studies and negotiate new partnerships with oversight from senior staff
Identify new vendors, tools, and data sources to deliver innovative epidemiology solutions for assets or disease areas
Contribute to strategic initiatives on the role of epidemiology at the departmental or R&D level
Represent GSK in scientific interactions with internal governance bodies, external regulators, and at international conferences
Plan and coordinate scientific dissemination of epidemiology data, including authoring regulatory documents, peer-reviewed publications, and presentations at national and international meetings
Partner with external groups conducting epidemiological studies globally and manage external collaborations

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Vice President, Global RWE and HEOR Strategy

Beam is seeking a dynamic, visionary, and strategic Vice President, Global RWE a...

Location

United States , Cambridge

Salary:

310000.00 - 400000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Master’s Degree or higher in Health Economics and Outcomes Research or a relevant discipline
Formal training in Epidemiology/Health Services Research required
20+ years’ experience in observational research study management AND data analytics, either within industry or with an observational research consulting firm
Proven track record in drug development, with rare disease experience and an existing network of hematologists preferred
Demonstrated ability to lead in a matrixed, cross-functional environment, combining strategic agility with strong business acumen
Independent, proactive operator with strong ownership
Cross functional collaboration with Clinical, Regulatory, Commercial, Medical Operations, and Publications while maintaining medical/scientific integrity
Excellent communication, collaboration, and problem-solving skills

Job Responsibility

Provide strategic input to disease prioritization, target product profiles, clinical trial protocols, clinical development plans, and regulatory submissions
lead development of clinical sections for Investigator’s Brochures, briefing books, safety updates, IND/NDA materials, and responses to Health Authority questions
Develop, validate, and integrate patient‑centered outcomes (PROs) into protocols and analyses
Interpret clinical trial results (including PROs and healthcare resource use) and partner with Clinical Development/Biostatistics on Statistical Analysis Plans (SAPs) and post‑hoc analyses
Lead a fit‑for‑purpose RWE strategy (EHR, claims, registries, hybrid/open datasets) including natural history/registry design and governance to inform endpoints, recruitment, and post‑authorization effectiveness/safety assessments
Develop and operationalize external/synthetic control arm approaches (e.g., matched registry cohorts, Bayesian borrowing) for single‑arm or small‑population studies typical in cell & gene therapy
Provide operational oversight of Medical Affairs evidence generation, including vendor/CRO governance, milestone/deliverable tracking, data‑quality plans, risk management, and on‑time execution across Medical Affairs–led studies
contribute to long‑term capability building (digital health, real‑world studies)
Elicit and integrate perspectives from patients, KOLs, policy leaders, and internal stakeholders (market access, marketing, patient advocacy) to ensure plans meet the needs of patients, HCPs, and payers
Support Market Access on internal and external payer/policy initiatives (pricing and reimbursement, unmet medical need, regional market dynamics, evidence gaps) across the portfolio

Fulltime

Head of Global Clinical Affairs

The Head of Global Clinical Affairs will be based in the metropolitan Bay area a...

Location

United States , Los Altos

Salary:

Not provided

FOCAL ONE

Expiration Date

Until further notice

Requirements

10+ years of relevant and current work experience in clinical affairs management including successes in therapeutic treatments and medical device technologies
Prior experience in urology, prostate cancer, benign prostatic hyperplasia and surgery preferred
Strong familiarity with FDA guidance and medical device regulations regarding clinical studies
Experience in launching and managing clinical trials for medical devices
Expertise in designing and managing U.S. and global clinical trials
Previous experience in post-market clinical studies and real-world evidence (RWE)
Proven track record working with thought leaders, KOLs, and clinical investigators
Excellent communication, presentation, project management and negotiation skills with the ability to influence decision-makers and stakeholders at all levels
Adaptable and able to thrive in a fast-paced environment with a continuous improvement mindset
Proven leader who enjoys building and managing a high performing team

Job Responsibility

Design and oversee the execution of clinical trials, including protocol development, site selection, and recruitment strategies
Develop and execute the clinical evidence strategy to support regulatory approval, reimbursement, health economics, and market access, including CMS and private payer engagement where applicable
Lead the clinical strategy for new products, ensuring clinical trials support product development goals, regulatory requirements, and commercialization efforts
Collaborate with regulatory teams to ensure clinical trials align with regulatory guidelines and support FDA, CE Mark and other global regulatory submissions
Support IDE submissions, post-approval studies, and global regulatory filings through robust clinical evidence generation
Oversee the analysis and interpretation of clinical data, ensuring results are communicated effectively to stakeholders
Lead the preparation of clinical study reports and presentations for regulatory bodies and Key Opinion Leaders
Develop and manage the clinical affairs budget, ensuring cost-effective execution of clinical trials while meeting timelines and quality standards
Partner with cross-functional teams (product development, marketing, regulatory, etc.) to integrate clinical findings into product development and go-to-market strategies
Initiate and maintain strong relationships with external clinical investigators, contract research organizations (CROs), clinical research sites, and Key Opinion Leaders

Fulltime

Senior Associate - RWE Application Development

This crucial role involves generating Real-World Evidence (RWE) to support Amgen...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's degree with 3-5 Years in Computer Science, Information Technology, or a related field
Proficient in R and R Shiny (Basic)
HTML (Intermediate)
CSS (Intermediate)
JavaScript (Intermediate)
At least four years of relevant career experience in full stack development
Strong working knowledge of HTML, CSS, and JavaScript programming
Scientific and technical excellence
Exceptional oral and written communication skills
Problem-solving abilities

Job Responsibility

Enhance and support existing R Shiny applications with a focus on front-end improvements
Provide support for the Atlas web-based application from the OHDSI community
Develop and implement web solutions using HTML, CSS, and JavaScript
Collaborate with stakeholders to understand their requirements and translate them into technical solutions
Participate in continuous integration and continuous deployment (CI/CD) processes
Manage and optimize data workflows to support efficient data processing and analysis
Maintain clear and effective communication with team members and stakeholders
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

What we offer

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

Senior Manager, Evidence Generation Lead

The medical Director, evidence generation is responsible for supporting strategi...

Location

Belgium , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

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

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

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development

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Manager - RWE Innovation Programming

Job Description

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