H-1B Visa Real World Evidence Jobs
Real World Evidence roles sit squarely within H-1B visa specialty occupation territory, requiring at least a bachelor's degree in epidemiology, biostatistics, health economics, or a closely related field. Pharma, biotech, and health technology employers sponsor H-1B visas for RWE analysts, scientists, and directors across study design, claims data analysis, and outcomes research functions.
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Get Access To All JobsINTRODUCTION
Work Your Magic with us! Start your next chapter and join EMD Serono.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your Role:
The Director, Real World Evidence Scientist is a highly experienced scientific expert who develops and owns the RWE strategy at the program(s) level, leads PRWE and CMS cross-functional initiatives, and interfaces directly with Global Program Teams (GPTs) and sub-teams. This role provides deep scientific leadership for the RWE strategy for one complex/high-priority product or group of products — leading and executing end-to-end RWE activities, providing expert oversight of studies, and representing our organization externally — without formal line management responsibilities.
Location: This position located in Billerica, MA with a hybrid (3x/week in office) schedule.
Key Responsibilities:
- Develop and own the RWE strategy at the program(s) level; interface directly with Global Program Teams (GPTs) and the subteams to integrate RWE into clinical development and regulatory strategies.
- Lead PRWE and CMS cross-functional initiatives.
- Ensure planning and management of outsourced deliverables are effectively performed to the highest quality and in a timely manner.
- Ensure objective results interpretation and adequate internal communication in support of informative decision making at GPT, PST, and Senior Management level.
- Lead and execute the RWE strategy for assigned product(s) without supervision. Provide leadership in the development of RWE strategy in Integrated Evidence Plans (IEPs) in close collaboration with cross-functional teams; ensure RWE generation needs are included in the IEP and secure budget for strategy execution.
- Collaborate closely with development team functions (GPS, GRA, GMU, GVD, GCD) and commercial teams (Market Access, Marketing, GVAP) as well as within PRWE.
- For one complex/high-priority product or group of products: adequately and timely design, plan, initiate, monitor, and finalize NIS (including protocol development and study report writing); peer review key documents (protocol, study report, briefing books for Health Authorities).
- Ensure the identification and selection of fit-for-purpose RWD sources for given research questions; contribute to the RWD strategy of the assigned therapeutic area.
- Solves complex or novel problems by analyzing research findings. Interprets critical internal or external business issues and develops innovative solutions to help sustain competitive advantage.
- Represent PRWE in cross-functional governance bodies; direct the RWE contribution for publications.
- Represent Company in external interactions requiring RWE expertise; represent PRWE at international conferences and consortia, contribute to peer-reviewed publications, conference presentations and scientific communications.
- Research and implement state-of-the-art RWE methodology; develop RWE standards focusing on efficient study designs to support sound R&D decision making.
- Lead process improvement to gain efficiency in current SOPs/WIs, and develop new ones as needed; promote lean concepts; encourage and foster collaboration at all levels within PRWE.
- Ensure methodological intelligence on appropriate regulations, guidance documents, and methodological developments; provide sound and up-to-date recommendations to NIS conduct.
- Handle interactions with Health Authorities and manage difficult issues with limited supervision; represent the company during approval processes including defense of RWE aspects with regulatory agencies.
- Provide high quality input to critical review assessments, expert statements, publications, and study proposals from internal and external sources.
- Develop new processes and SOPs relevant for PRWE at Company and customize existing ones according to lean concepts.
- Manage budget associated with program-level RWE projects; maintain overview of budget spend by functional and program budget.
- Act as scientific mentor for less senior scientists within the function.
Who You Are:
Minimum Qualifications:
- Master's or PhD in Epidemiology, Public Health, Health Economics and Outcomes Research, or Biostatistics.
- 8-10 years of RWE experience in CRO, or pharmaceutical/biotechnology industry settings.
- Demonstrated strong experience in studies based on secondary data use (claims, EMR, registries) across different healthcare environments (Europe, US, Asia).
- Experience in studies based on primary data collection.
- Knowledge of federated data networks (CPRD, Optum, IQVIA, TriNetX) and OMOP CDM or FHIR data standards.
Preferred Qualifications:
- Strong methodological skills; medical/pharmacological/pharmacovigilance knowledge.
- Experience in project management as a global RWE leader, preferably in multi-cultural environments.
- Strong expertise in drug development, including interfaces and interdependencies of clinical development with other functions.
- Experience in global regulatory and/or payer submissions and interactions.
- Experience in at least one key therapeutic area (Oncology, Neurology & Immunology).
- Excellent understanding of the regulatory environment and standards.
- Track record of thought leadership (publications, conference presentations, advisory roles).
- Experience with AI/ML applications in RWE, including NLP.
- Experience with patient-reported outcomes (PROs) and health technology assessment (HTA).
- Experience in budget oversight and vendor management in global organizations.
- Knowledge of health equity and DEI principles in evidence generation.
- Involvement in industry working groups, regulatory advisory committees, or professional society leadership.
Pay Range for this position: $172,000 - 258,000
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
LI-hybrid
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
INTRODUCTION
Work Your Magic with us! Start your next chapter and join EMD Serono.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your Role:
The Director, Real World Evidence Scientist is a highly experienced scientific expert who develops and owns the RWE strategy at the program(s) level, leads PRWE and CMS cross-functional initiatives, and interfaces directly with Global Program Teams (GPTs) and sub-teams. This role provides deep scientific leadership for the RWE strategy for one complex/high-priority product or group of products — leading and executing end-to-end RWE activities, providing expert oversight of studies, and representing our organization externally — without formal line management responsibilities.
Location: This position located in Billerica, MA with a hybrid (3x/week in office) schedule.
Key Responsibilities:
- Develop and own the RWE strategy at the program(s) level; interface directly with Global Program Teams (GPTs) and the subteams to integrate RWE into clinical development and regulatory strategies.
- Lead PRWE and CMS cross-functional initiatives.
- Ensure planning and management of outsourced deliverables are effectively performed to the highest quality and in a timely manner.
- Ensure objective results interpretation and adequate internal communication in support of informative decision making at GPT, PST, and Senior Management level.
- Lead and execute the RWE strategy for assigned product(s) without supervision. Provide leadership in the development of RWE strategy in Integrated Evidence Plans (IEPs) in close collaboration with cross-functional teams; ensure RWE generation needs are included in the IEP and secure budget for strategy execution.
- Collaborate closely with development team functions (GPS, GRA, GMU, GVD, GCD) and commercial teams (Market Access, Marketing, GVAP) as well as within PRWE.
- For one complex/high-priority product or group of products: adequately and timely design, plan, initiate, monitor, and finalize NIS (including protocol development and study report writing); peer review key documents (protocol, study report, briefing books for Health Authorities).
- Ensure the identification and selection of fit-for-purpose RWD sources for given research questions; contribute to the RWD strategy of the assigned therapeutic area.
- Solves complex or novel problems by analyzing research findings. Interprets critical internal or external business issues and develops innovative solutions to help sustain competitive advantage.
- Represent PRWE in cross-functional governance bodies; direct the RWE contribution for publications.
- Represent Company in external interactions requiring RWE expertise; represent PRWE at international conferences and consortia, contribute to peer-reviewed publications, conference presentations and scientific communications.
- Research and implement state-of-the-art RWE methodology; develop RWE standards focusing on efficient study designs to support sound R&D decision making.
- Lead process improvement to gain efficiency in current SOPs/WIs, and develop new ones as needed; promote lean concepts; encourage and foster collaboration at all levels within PRWE.
- Ensure methodological intelligence on appropriate regulations, guidance documents, and methodological developments; provide sound and up-to-date recommendations to NIS conduct.
- Handle interactions with Health Authorities and manage difficult issues with limited supervision; represent the company during approval processes including defense of RWE aspects with regulatory agencies.
- Provide high quality input to critical review assessments, expert statements, publications, and study proposals from internal and external sources.
- Develop new processes and SOPs relevant for PRWE at Company and customize existing ones according to lean concepts.
- Manage budget associated with program-level RWE projects; maintain overview of budget spend by functional and program budget.
- Act as scientific mentor for less senior scientists within the function.
Who You Are:
Minimum Qualifications:
- Master's or PhD in Epidemiology, Public Health, Health Economics and Outcomes Research, or Biostatistics.
- 8-10 years of RWE experience in CRO, or pharmaceutical/biotechnology industry settings.
- Demonstrated strong experience in studies based on secondary data use (claims, EMR, registries) across different healthcare environments (Europe, US, Asia).
- Experience in studies based on primary data collection.
- Knowledge of federated data networks (CPRD, Optum, IQVIA, TriNetX) and OMOP CDM or FHIR data standards.
Preferred Qualifications:
- Strong methodological skills; medical/pharmacological/pharmacovigilance knowledge.
- Experience in project management as a global RWE leader, preferably in multi-cultural environments.
- Strong expertise in drug development, including interfaces and interdependencies of clinical development with other functions.
- Experience in global regulatory and/or payer submissions and interactions.
- Experience in at least one key therapeutic area (Oncology, Neurology & Immunology).
- Excellent understanding of the regulatory environment and standards.
- Track record of thought leadership (publications, conference presentations, advisory roles).
- Experience with AI/ML applications in RWE, including NLP.
- Experience with patient-reported outcomes (PROs) and health technology assessment (HTA).
- Experience in budget oversight and vendor management in global organizations.
- Knowledge of health equity and DEI principles in evidence generation.
- Involvement in industry working groups, regulatory advisory committees, or professional society leadership.
Pay Range for this position: $172,000 - 258,000
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
LI-hybrid
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
See all H-1B Visa Real World Evidence Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Real World Evidence Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Real World Evidence
Match your degree to the RWE role
USCIS scrutinizes whether your degree field directly relates to the position. An epidemiology or biostatistics degree maps cleanly to RWE scientist roles; a general biology degree may trigger an RFE if the job description emphasizes statistical modeling or health economics.
Use OFLC Wage Search before negotiating
RWE roles span multiple SOC codes depending on whether your work is classified as epidemiology, medical science, or operations research. Pull prevailing wage levels for each applicable code using OFLC Wage Search so you can evaluate whether an offer meets Level I through Level IV thresholds before signing.
Target sponsors in pharma and health tech
Pharma manufacturers, contract research organizations, and health data companies file the highest volume of H-1B LCAs for RWE functions. Search Migrate Mate to filter employers by verified H-1B filing history specifically for outcomes research and epidemiology job titles.
Confirm E-Verify enrollment for STEM OPT transitions
If you're extending OPT before your H-1B starts, the employer must be enrolled in E-Verify. RWE roles at smaller biotech startups sometimes lack enrollment, which blocks your STEM OPT extension even if the H-1B petition is already approved.
Distinguish contract versus full-time sponsorship early
Many RWE positions are staffed through CROs or consulting firms on a contract basis. The H-1B petitioner must be your direct employer of record, not the end client. Clarify which entity will file your I-129 and control your day-to-day work before accepting a contract offer.
Request premium processing at the offer stage
RWE project timelines are often tied to drug development milestones, so a delayed H-1B approval can push your start date past a critical study phase. Ask during negotiations whether the employer will elect premium processing, which USCIS currently adjudicates within 15 business days.
H-1B Visa Real World Evidence: Frequently Asked Questions
Does a Real World Evidence role qualify as an H-1B specialty occupation?
Yes, RWE positions qualify when the job requires at least a bachelor's degree in a specific field such as epidemiology, biostatistics, health economics, or pharmacoepidemiology. The key is that a theoretical and practical body of specialized knowledge must be required to perform the job. Roles that accept any bachelor's degree, regardless of field, are more vulnerable to USCIS specialty occupation challenges during adjudication.
Which employers sponsor H-1B visas for RWE jobs?
Pharmaceutical companies, contract research organizations, health data analytics firms, and medical device manufacturers are the primary H-1B sponsors for RWE functions. You can browse employers with verified H-1B filing history for outcomes research and epidemiology roles on Migrate Mate, which surfaces DOL Labor Condition Application data by employer and job title.
How does the H-1B cap lottery affect RWE job seekers?
Most RWE roles are with cap-subject employers, meaning your petition enters the annual H-1B lottery limited to 85,000 slots. Registrations are accepted each March for an October 1 start date. If your employer is a university, nonprofit research institution, or government research entity, the cap-exempt category may apply and your petition can be filed at any time.
What SOC code typically applies to Real World Evidence roles?
RWE job titles map to several SOC codes depending on the core function. Epidemiologists, medical scientists, operations research analysts, and statisticians each have distinct classifications under DOL's occupational system. Your employer's LCA must list the SOC code that best reflects your actual duties, which directly determines the prevailing wage level used to set your minimum salary. Checking O*NET for your specific role description helps confirm the correct classification.
Can I transfer my H-1B to a new RWE employer mid-project?
Yes, H-1B portability lets you start working for a new employer as soon as the new petition is filed, without waiting for approval, as long as you've been in valid H-1B status for at least 180 days. RWE professionals switching between a pharma sponsor and a CRO, or moving from a research role to a consulting firm, commonly use this mechanism to avoid gaps in authorized work status.