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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Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical program for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families, and communities.
Role Summary
The Senior Director, Epidemiology and Real World Evidence (RWE) is an enterprise expert in the application of epidemiology and real-world evidence to support Medical Affairs–led scientific and clinical objectives. This role shapes and delivers rigorous RWE strategies that inform clinical decision-making, advance disease and treatment understanding, and enable high-quality scientific engagement across the portfolio. The role provides strategic leadership for interventional, observational, and epidemiologic research, including Phase 3b and Phase 4 studies as well as prevalence and incidence studies, to support endpoint development, safety and pharmacovigilance, regulatory interactions, and medical decision-making. The Senior Director partners closely with Global Medical Directors, HEOR, Clinical Development, Biometrics, Drug Safety/Pharmacovigilance, Regulatory Affairs, Value & Access, and Commercial to generate and interpret evidence that enables asset-level Medical Affairs strategies. This position also strengthens epidemiology and RWE capabilities across Medical Affairs and Dyne through consistent standards, governance, and scientific excellence. This role is based in Waltham, MA.
Primary Responsibilities Include
Strategic Leadership, Governance & Enterprise Partnership
- Serves as Dyne’s scientific and methodological leader for interventional, observational, and epidemiologic research, including Phase 3b, Phase 4, and prevalence/incidence studies, to address Medical Affairs–driven evidence needs across the portfolio
- Partners with Medical Affairs and HEOR to develop and execute an enterprise-level epidemiology and RWE strategy aligned with organizational objectives
- Establishes governance, best practices, and standards for epidemiologic and real-world research across Medical Affairs
- Provides expert guidance to Global Medical Directors and cross-functional teams on the appropriate use, interpretation, and limitations of real-world data
- Acts as an internal thought leader in epidemiology, RWE, and observational research methodologies
Epidemiology, Observational & Interventional Research
- Leads the design, execution, and interpretation of epidemiologic and observational studies supporting Medical Affairs objectives, including chart reviews, post hoc analyses, prospective observational studies, investigator-initiated studies, Phase 3b/4 studies, and prevalence/incidence studies
- Partners with Clinical Development and Biometrics to inform endpoint development, protocol design, and external control strategies that address key evidence needs for clinical decision-making
- Ensures studies are scientifically rigorous, fit-for-purpose, compliant, and publication-ready
- Oversees scientific dissemination through peer-reviewed publications, congress presentations, and external scientific engagement
Safety, Pharmacovigilance & Regulatory Support
- Provides epidemiology and RWE leadership in support of Drug Safety and Pharmacovigilance activities
- Partners with Drug Safety/Pharmacovigilance and Clinical Development to support safety surveillance, signal evaluation, and benefit–risk assessment
- Designs and oversees post-authorization safety studies (PASS), registry-based safety evaluations, observational safety studies, and long-term safety assessments
- Supports evaluation of safety signals through background incidence rate analyses, observed-to-expected analyses, and other epidemiologic approaches
- Contributes epidemiologic expertise to risk management plans, safety specifications, and safety-related regulatory documentation, as appropriate
Cross-Functional Collaboration, Capability Building & Operational Excellence
- Collaborates with Global Medical Directors, HEOR, Regulatory Affairs, Value & Access, Commercial, and other partners to support asset-level integrated evidence plans
- Engages with health authorities in collaboration with Regulatory Affairs on epidemiology- and RWE-related interactions
- Builds and maintains relationships with external epidemiologists, academic collaborators, consortia, and patient registries
- Strengthens epidemiology and RWE capabilities across Medical Affairs through training, mentorship, and knowledge sharing
- Manages budgets, timelines, vendors, and external partners to ensure quality, compliance, and operational excellence
- Monitors advances in real-world data sources, analytics, and epidemiologic methods to drive innovation and continuous improvement
Education And Skills Requirements
- Advanced degree in epidemiology, public health, health services research, or a related discipline
- 15+ years of relevant experience in epidemiology, real-world evidence, observational research, or related scientific disciplines; or equivalent combination of education and experience
- Deep expertise in epidemiologic methods, observational study design, real-world data sources, and application of RWE to safety surveillance and pharmacovigilance
- Demonstrated experience leading post-authorization safety studies and contributing to regulatory documentation
- Proven ability to partner effectively across Medical Affairs, Clinical Development, Drug Safety/Pharmacovigilance, HEOR, Regulatory Affairs, and Market Access in a matrix environment
- Strong track record of scientific communication, peer-reviewed publication, and external scientific engagement
- Experience in rare diseases and/or neuromuscular disorders strongly preferred
- Strong analytical, strategic, and problem-solving skills with the ability to operate as an enterprise expert and influence without authority
- Exceptional written, verbal, and presentation skills
- Willingness to travel up to approximately 30%
- High level of integrity, ethics, compliance, and transparency, with flexibility to adapt to evolving scientific and organizational needs
- Strong alignment with Dyne’s mission, values, and commitment to patients
MA Pay Range
$245,000 - $300,000 USD
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Company Overview
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical program for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families, and communities.
Role Summary
The Senior Director, Epidemiology and Real World Evidence (RWE) is an enterprise expert in the application of epidemiology and real-world evidence to support Medical Affairs–led scientific and clinical objectives. This role shapes and delivers rigorous RWE strategies that inform clinical decision-making, advance disease and treatment understanding, and enable high-quality scientific engagement across the portfolio. The role provides strategic leadership for interventional, observational, and epidemiologic research, including Phase 3b and Phase 4 studies as well as prevalence and incidence studies, to support endpoint development, safety and pharmacovigilance, regulatory interactions, and medical decision-making. The Senior Director partners closely with Global Medical Directors, HEOR, Clinical Development, Biometrics, Drug Safety/Pharmacovigilance, Regulatory Affairs, Value & Access, and Commercial to generate and interpret evidence that enables asset-level Medical Affairs strategies. This position also strengthens epidemiology and RWE capabilities across Medical Affairs and Dyne through consistent standards, governance, and scientific excellence. This role is based in Waltham, MA.
Primary Responsibilities Include
Strategic Leadership, Governance & Enterprise Partnership
- Serves as Dyne’s scientific and methodological leader for interventional, observational, and epidemiologic research, including Phase 3b, Phase 4, and prevalence/incidence studies, to address Medical Affairs–driven evidence needs across the portfolio
- Partners with Medical Affairs and HEOR to develop and execute an enterprise-level epidemiology and RWE strategy aligned with organizational objectives
- Establishes governance, best practices, and standards for epidemiologic and real-world research across Medical Affairs
- Provides expert guidance to Global Medical Directors and cross-functional teams on the appropriate use, interpretation, and limitations of real-world data
- Acts as an internal thought leader in epidemiology, RWE, and observational research methodologies
Epidemiology, Observational & Interventional Research
- Leads the design, execution, and interpretation of epidemiologic and observational studies supporting Medical Affairs objectives, including chart reviews, post hoc analyses, prospective observational studies, investigator-initiated studies, Phase 3b/4 studies, and prevalence/incidence studies
- Partners with Clinical Development and Biometrics to inform endpoint development, protocol design, and external control strategies that address key evidence needs for clinical decision-making
- Ensures studies are scientifically rigorous, fit-for-purpose, compliant, and publication-ready
- Oversees scientific dissemination through peer-reviewed publications, congress presentations, and external scientific engagement
Safety, Pharmacovigilance & Regulatory Support
- Provides epidemiology and RWE leadership in support of Drug Safety and Pharmacovigilance activities
- Partners with Drug Safety/Pharmacovigilance and Clinical Development to support safety surveillance, signal evaluation, and benefit–risk assessment
- Designs and oversees post-authorization safety studies (PASS), registry-based safety evaluations, observational safety studies, and long-term safety assessments
- Supports evaluation of safety signals through background incidence rate analyses, observed-to-expected analyses, and other epidemiologic approaches
- Contributes epidemiologic expertise to risk management plans, safety specifications, and safety-related regulatory documentation, as appropriate
Cross-Functional Collaboration, Capability Building & Operational Excellence
- Collaborates with Global Medical Directors, HEOR, Regulatory Affairs, Value & Access, Commercial, and other partners to support asset-level integrated evidence plans
- Engages with health authorities in collaboration with Regulatory Affairs on epidemiology- and RWE-related interactions
- Builds and maintains relationships with external epidemiologists, academic collaborators, consortia, and patient registries
- Strengthens epidemiology and RWE capabilities across Medical Affairs through training, mentorship, and knowledge sharing
- Manages budgets, timelines, vendors, and external partners to ensure quality, compliance, and operational excellence
- Monitors advances in real-world data sources, analytics, and epidemiologic methods to drive innovation and continuous improvement
Education And Skills Requirements
- Advanced degree in epidemiology, public health, health services research, or a related discipline
- 15+ years of relevant experience in epidemiology, real-world evidence, observational research, or related scientific disciplines; or equivalent combination of education and experience
- Deep expertise in epidemiologic methods, observational study design, real-world data sources, and application of RWE to safety surveillance and pharmacovigilance
- Demonstrated experience leading post-authorization safety studies and contributing to regulatory documentation
- Proven ability to partner effectively across Medical Affairs, Clinical Development, Drug Safety/Pharmacovigilance, HEOR, Regulatory Affairs, and Market Access in a matrix environment
- Strong track record of scientific communication, peer-reviewed publication, and external scientific engagement
- Experience in rare diseases and/or neuromuscular disorders strongly preferred
- Strong analytical, strategic, and problem-solving skills with the ability to operate as an enterprise expert and influence without authority
- Exceptional written, verbal, and presentation skills
- Willingness to travel up to approximately 30%
- High level of integrity, ethics, compliance, and transparency, with flexibility to adapt to evolving scientific and organizational needs
- Strong alignment with Dyne’s mission, values, and commitment to patients
MA Pay Range
$245,000 - $300,000 USD
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
See all H-1B Visa Real World Evidence Jobs
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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.