Risk Data Analyst Jobs in USA with Visa Sponsorship
Risk Data Analysts are strong candidates for H-1B visa and O-1 visa sponsorship. The role consistently qualifies as a specialty occupation requiring a degree in statistics, mathematics, finance, or a related quantitative field, and employers in banking, insurance, and fintech sponsor regularly. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsPosition Job Title: Senior Principal Risk Based Quality Management Data Monitor
Location: Research Triangle Park, NC (preferred, not mandatory)
About This Role
As a Senior Principal Risk Based Quality Management Data Monitor, you will be a key contributor to the creation of Biogen’s in-house RBQM strategy and process implementation. You will play a critical role in shaping how clinical trial data is monitored, protected, and elevated to the highest quality standards. You will be at the forefront of implementing Risk-Based Quality Management (RBQM) strategies—ensuring patient safety, regulatory compliance, and data integrity across all phases of clinical research. You’ll collaborate closely with biostatistics, data science, safety/pharmacovigilance, clinical operations, and vendors to detect and triage signals early, optimize KRIs/QTLs, and drive continuous process and technology improvements across the portfolio.
This position is ideal for someone who thrives on analytical thinking, cross-functional collaboration, and using RBQM and advanced analytics to keep clinical trials running smoothly and safely.
What You’ll Do
- Risk Identification & Assessment
- Partner with cross functional teams to identify critical data and processes (CDPs) and associated study risks
- Contribute significantly to the development and maintenance of the study-specific Risk Assessment Categorization Tool (RACT) or equivalent by providing a clinical data management focused perspective
- Prioritize risks and signals based on patient safety impact, data integrity, severity, likelihood, and detectability
- Centralized Monitoring
- Conduct proactive, ongoing data reviews using RBQM dashboards and analytics tools
- Ensure timely escalation and follow up on any signals or anomalies
- Triaging: Prioritize, Escalate, and Track signals
- Data Quality Oversight
- Review and validate data across EDC, safety, and other clinical systems to ensure consistency and quality
- Oversee data cleaning timelines and ensure adherence to risk mitigation plans
- Partner with study teams to ensure data flow mapping supports early risk detection
- Issue Management
- Document and communicate findings clearly and effectively to study teams
- Trigger and/or support Corrective and Preventive Actions (CAPA)
- Participate in root cause analyses for major deviations or quality concerns
- Compliance & Governance
- Ensure alignment with ICH-GCP, FDA/EMA regulations, and internal SOPs.
- Support audit and inspection readiness related to RBQM and centralized monitoring
- Technology Enablement & Continuous Improvement
- Contribute to and/or lead process enhancements, technology upgrades, and RBQM best practices
- Partner with platform/analytics teams to enhance dashboards and detection logic; perform UAT and help shape product roadmaps
- Provide training, guidance, and mentorship on RBQM concepts to study teams.
Who You Are
You’re a data-driven problem solver with a deep understanding of clinical trial operations. You excel in fast-paced, matrixed environments and are energized by collaborating with diverse teams. You can spot data issues before they escalate. You anticipate risk, communicate insights clearly, drive actions, and continuously look for ways to improve processes. You balance rigor with pragmatism, communicate crisply across functions, and stay laser focused on patient safety and data integrity.
Required Skills
- 7+ years of experience in clinical data management, clinical operations or Academia with strong scientific knowledge in at least one therapeutic area within the Biogen portfolio
- RBQM-focused roles within pharma or CRO settings
- Hands-on experience with centralized monitoring tools (RBQM platforms/dashboards), KRIs, QTLs, or similar RBQM methodologies
- Proficiency with EDC systems and data visualization tools
- High attention to detail including proven ability to manage multiple, competing priorities
- Experience supporting audits/inspections
- Understanding of clinical data flow, study endpoints, and regulatory requirements
- Strong analytical and critical-thinking abilities
- Excellent communication and stakeholder management skills
- Ability to adapt and thrive in a dynamic, cross-functional environment
- Risk-based thinking & structured problem-solving
- Data driven decision-making
- Collaborative teamwork across clinical and operational functions
- Deep understanding of drug development and biopharmaceutical industry required
- Fluent English (oral and written)
- Demonstrated ability to identify data trends, signals, outliers, and risk indicators using listings, visualizations, metrics, and analytics tools
- Strong knowledge of GCP, ICH E6(R2)/E6(R3), regulatory expectations, and industry data quality best practices
- Demonstrated problem-solving skills with a continuous improvement mindset and enthusiasm for scientific data excellence.
Education Requirements/Preferred Skills
- Bachelor’s degree in life sciences, health sciences, pharmacy, nursing, data science, or related discipline; advanced degree (MS, PharmD, PhD) strongly preferred
- Experience with implementing consistent clinical and scientific data review processes
- Experience defining and calibrating KRIs/QTLs at study and portfolio levels
- Experience with cross study trending and systemic risk analysis
- Therapeutic area familiarity aligned to portfolio (e.g., neuroscience, rare disease, immunology)
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry, and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
Job Level: Management
Additional Information
The base compensation range for this role is: -
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Position Job Title: Senior Principal Risk Based Quality Management Data Monitor
Location: Research Triangle Park, NC (preferred, not mandatory)
About This Role
As a Senior Principal Risk Based Quality Management Data Monitor, you will be a key contributor to the creation of Biogen’s in-house RBQM strategy and process implementation. You will play a critical role in shaping how clinical trial data is monitored, protected, and elevated to the highest quality standards. You will be at the forefront of implementing Risk-Based Quality Management (RBQM) strategies—ensuring patient safety, regulatory compliance, and data integrity across all phases of clinical research. You’ll collaborate closely with biostatistics, data science, safety/pharmacovigilance, clinical operations, and vendors to detect and triage signals early, optimize KRIs/QTLs, and drive continuous process and technology improvements across the portfolio.
This position is ideal for someone who thrives on analytical thinking, cross-functional collaboration, and using RBQM and advanced analytics to keep clinical trials running smoothly and safely.
What You’ll Do
- Risk Identification & Assessment
- Partner with cross functional teams to identify critical data and processes (CDPs) and associated study risks
- Contribute significantly to the development and maintenance of the study-specific Risk Assessment Categorization Tool (RACT) or equivalent by providing a clinical data management focused perspective
- Prioritize risks and signals based on patient safety impact, data integrity, severity, likelihood, and detectability
- Centralized Monitoring
- Conduct proactive, ongoing data reviews using RBQM dashboards and analytics tools
- Ensure timely escalation and follow up on any signals or anomalies
- Triaging: Prioritize, Escalate, and Track signals
- Data Quality Oversight
- Review and validate data across EDC, safety, and other clinical systems to ensure consistency and quality
- Oversee data cleaning timelines and ensure adherence to risk mitigation plans
- Partner with study teams to ensure data flow mapping supports early risk detection
- Issue Management
- Document and communicate findings clearly and effectively to study teams
- Trigger and/or support Corrective and Preventive Actions (CAPA)
- Participate in root cause analyses for major deviations or quality concerns
- Compliance & Governance
- Ensure alignment with ICH-GCP, FDA/EMA regulations, and internal SOPs.
- Support audit and inspection readiness related to RBQM and centralized monitoring
- Technology Enablement & Continuous Improvement
- Contribute to and/or lead process enhancements, technology upgrades, and RBQM best practices
- Partner with platform/analytics teams to enhance dashboards and detection logic; perform UAT and help shape product roadmaps
- Provide training, guidance, and mentorship on RBQM concepts to study teams.
Who You Are
You’re a data-driven problem solver with a deep understanding of clinical trial operations. You excel in fast-paced, matrixed environments and are energized by collaborating with diverse teams. You can spot data issues before they escalate. You anticipate risk, communicate insights clearly, drive actions, and continuously look for ways to improve processes. You balance rigor with pragmatism, communicate crisply across functions, and stay laser focused on patient safety and data integrity.
Required Skills
- 7+ years of experience in clinical data management, clinical operations or Academia with strong scientific knowledge in at least one therapeutic area within the Biogen portfolio
- RBQM-focused roles within pharma or CRO settings
- Hands-on experience with centralized monitoring tools (RBQM platforms/dashboards), KRIs, QTLs, or similar RBQM methodologies
- Proficiency with EDC systems and data visualization tools
- High attention to detail including proven ability to manage multiple, competing priorities
- Experience supporting audits/inspections
- Understanding of clinical data flow, study endpoints, and regulatory requirements
- Strong analytical and critical-thinking abilities
- Excellent communication and stakeholder management skills
- Ability to adapt and thrive in a dynamic, cross-functional environment
- Risk-based thinking & structured problem-solving
- Data driven decision-making
- Collaborative teamwork across clinical and operational functions
- Deep understanding of drug development and biopharmaceutical industry required
- Fluent English (oral and written)
- Demonstrated ability to identify data trends, signals, outliers, and risk indicators using listings, visualizations, metrics, and analytics tools
- Strong knowledge of GCP, ICH E6(R2)/E6(R3), regulatory expectations, and industry data quality best practices
- Demonstrated problem-solving skills with a continuous improvement mindset and enthusiasm for scientific data excellence.
Education Requirements/Preferred Skills
- Bachelor’s degree in life sciences, health sciences, pharmacy, nursing, data science, or related discipline; advanced degree (MS, PharmD, PhD) strongly preferred
- Experience with implementing consistent clinical and scientific data review processes
- Experience defining and calibrating KRIs/QTLs at study and portfolio levels
- Experience with cross study trending and systemic risk analysis
- Therapeutic area familiarity aligned to portfolio (e.g., neuroscience, rare disease, immunology)
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry, and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
Job Level: Management
Additional Information
The base compensation range for this role is: -
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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Get Access To All JobsTips for Finding Visa Sponsorship as a Risk Data Analyst
Target financial services and insurance employers first
Banks, insurance companies, and fintech firms file the highest volume of H-1B petitions for Risk Data Analyst roles. These employers have established immigration infrastructure and legal teams already familiar with sponsoring quantitative risk positions.
Document the degree-to-role connection explicitly
USCIS scrutinizes specialty occupation claims for analyst titles. Your offer letter and employer support letter should explicitly state that the role requires a bachelor's degree or higher in a specific quantitative field, not just any degree.
Emphasize technical tools and methodologies in your resume
SQL, Python, R, SAS, and risk modeling frameworks signal genuine specialty occupation work. Resumes that read as general business analysis rather than quantitative risk work are harder for employers to defend in an H-1B petition.
Understand that large employers can file year-round
Cap-exempt employers, including universities and nonprofit research organizations, can sponsor H-1B visas outside the April lottery window. For cap-subject employers, the registration window opens in March each year.
An O-1A visa is viable if you have published research or industry recognition
Risk Data Analysts with published papers, speaking credits at industry conferences, or recognized contributions to risk modeling methodology may qualify for O-1A extraordinary ability status, which has no lottery and no annual cap.
Confirm the employer has sponsored before before accepting an offer
Not every employer offering to sponsor has actually completed the process before. Ask specifically whether their legal or HR team has filed H-1B petitions previously, since first-time sponsors often underestimate the timeline and complexity involved.
Frequently Asked Questions
Does a Risk Data Analyst role qualify as a specialty occupation for H-1B purposes?
Yes, in most cases. USCIS requires that the position normally requires a bachelor's degree or higher in a specific field such as statistics, mathematics, finance, economics, or data science. The challenge arises when job descriptions are written loosely and accept any degree, which weakens the specialty occupation argument. Employers should work with immigration counsel to draft job descriptions that reflect the actual technical requirements of the role.
Which degree fields are most defensible for a Risk Data Analyst H-1B petition?
Statistics, mathematics, actuarial science, finance, economics, data science, and computer science are the strongest degree fields for this role. Engineering degrees with a quantitative focus are also accepted. A general business administration degree is harder to defend unless the role's duties are highly technical and the employer can document why that specific background is required.
How common is H-1B sponsorship for Risk Data Analyst positions?
Sponsorship is relatively common in this occupation, particularly at large financial institutions, insurance carriers, consulting firms, and fintech companies. These employers file H-1B visa petitions for quantitative risk roles with regularity and have legal teams experienced in supporting the specialty occupation argument. Smaller firms may be willing but lack the infrastructure to move quickly. Migrate Mate lists verified sponsoring employers actively hiring for data and risk roles.
Can a Risk Data Analyst on OPT work for a company while waiting for H-1B approval?
Yes. If you're on F-1 OPT or STEM OPT, you can work for an employer who files your H-1B petition under cap-gap protections. If your OPT expires before October 1 and your petition is selected and pending, cap-gap extends your work authorization automatically through September 30. STEM OPT extensions give you up to 36 months of work authorization, providing a longer runway for the H-1B process.
Is a Risk Data Analyst role viable for an O-1A visa instead of H-1B?
It can be, but the bar is high. The O-1A requires demonstrating extraordinary ability through criteria such as published research, industry awards, high compensation relative to peers, or contributions of major significance to the field. A strong risk analyst with academic publications, conference presentations, or recognized methodology contributions has a credible O-1A case. The advantage is no lottery and no annual cap, making it worth exploring if your background supports it.
What is the prevailing wage requirement for sponsored Risk Data Analyst jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.