H-1B Visa Programmer Analyst Jobs
Programmer Analyst roles sit squarely within H-1B visa specialty occupation territory, requiring at least a bachelor's degree in computer science, information systems, or a closely related field. Employers filing LCAs for this title span enterprise software, healthcare IT, financial services, and consulting, making it one of the more consistently sponsored technical roles in the H-1B program.
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Get Access To All JobsJob Title: Senior Statistical Programmer – Clinical Development
Location: Remote
Job Summary
We are seeking an experienced Senior Statistical Programmer with 10+ years of hands-on experience working directly within pharmaceutical or biotechnology sponsor organizations. The ideal candidate will have extensive expertise in clinical trial statistical programming, clinical data analysis, CDISC standards, SDTM, ADaM, SAS programming, and regulatory submission deliverables. The candidate must have strong sponsor-side experience supporting clinical development programs from study startup through database lock, clinical study report (CSR) preparation, and regulatory submissions to the FDA and other global health authorities. Candidates with exclusively CRO experience will not be considered. Prior experience working directly for US-based pharmaceutical or biotechnology sponsors is mandatory.
Key Responsibilities
- Lead and independently execute statistical programming activities for Phase I–IV clinical trials across multiple therapeutic areas.
- Develop, validate, and maintain SDTM and ADaM datasets in accordance with CDISC standards and regulatory requirements.
- Design, develop, validate, and maintain complex SAS programs for clinical trial analysis and reporting.
- Generate Tables, Listings, and Figures (TLFs) for interim analyses, final analyses, clinical study reports, and regulatory submissions.
- Provide programming support for regulatory submissions, including FDA NDA, BLA, and IND applications.
- Develop and review analysis datasets, define.xml, annotated CRFs, and other regulatory submission-related documentation.
- Collaborate closely with Biostatisticians, Clinical Data Management, Clinical Operations, Medical Writing, and Regulatory Affairs teams.
- Participate in statistical analysis plan (SAP) reviews and provide programming input into analysis specifications.
- Perform independent QC and validation of statistical programs, datasets, and TLF outputs.
- Ensure compliance with CDISC, FDA, ICH, GCP, and internal sponsor programming standards.
- Troubleshoot complex programming issues and provide technical guidance to statistical programming teams.
- Support data review, data cleaning, database lock, and submission readiness activities.
- Manage programming deliverables, timelines, and quality expectations across multiple clinical studies.
- Participate in sponsor-side governance meetings and provide updates on programming progress, risks, and deliverables.
Requirements
- 10+ years of hands-on Statistical Programming experience within pharmaceutical or biotechnology sponsor organizations.
- Strong expertise in SAS Base, SAS Macro, SAS/STAT, PROC SQL, and advanced SAS programming.
- Extensive experience with CDISC SDTM and ADaM implementation.
- Strong understanding of CDISC implementation guides and regulatory submission standards.
- Expertise in developing and validating complex Tables, Listings, and Figures (TLFs).
- Experience with clinical trial data structures, analysis datasets, and statistical reporting.
- Strong knowledge of FDA regulatory submission requirements and electronic Common Technical Document (eCTD) deliverables.
- Experience with Define-XML, Pinnacle 21, and CDISC compliance validation.
- Expertise in clinical trial reporting, data review, and submission deliverables.
- Strong understanding of clinical development processes and clinical trial data standards.
- Direct employment or direct project experience within pharmaceutical or biotechnology sponsor organizations.
- Experience working on sponsor-owned clinical development programs.
- Direct collaboration with sponsor Biostatistics, Clinical Development, Clinical Data Management, and Regulatory teams.
- Ownership of statistical programming deliverables and submission activities.
- Experience supporting FDA regulatory submissions, including NDA/BLA packages.
- Ability to independently manage programming deliverables, timelines, and quality expectations.
Preferred Qualifications
- Experience in Oncology, Immunology, Hematology, Neurology, or Cardiovascular clinical trials.
- Experience supporting global Phase II and Phase III clinical development programs.
- Knowledge of R programming in addition to SAS.
- Experience with SAS Drug Development (SDD), SAS Life Science Analytics Framework (LSAF), or similar sponsor programming environments.
- Familiarity with Pinnacle 21 Enterprise and regulatory submission processes.
- Experience mentoring junior and mid-level statistical programmers.
Education
- Master's degree or PhD in Statistics, Biostatistics, Mathematics, Computer Science, or a related quantitative discipline.
- Equivalent industry experience may be considered.
Job Title: Senior Statistical Programmer – Clinical Development
Location: Remote
Job Summary
We are seeking an experienced Senior Statistical Programmer with 10+ years of hands-on experience working directly within pharmaceutical or biotechnology sponsor organizations. The ideal candidate will have extensive expertise in clinical trial statistical programming, clinical data analysis, CDISC standards, SDTM, ADaM, SAS programming, and regulatory submission deliverables. The candidate must have strong sponsor-side experience supporting clinical development programs from study startup through database lock, clinical study report (CSR) preparation, and regulatory submissions to the FDA and other global health authorities. Candidates with exclusively CRO experience will not be considered. Prior experience working directly for US-based pharmaceutical or biotechnology sponsors is mandatory.
Key Responsibilities
- Lead and independently execute statistical programming activities for Phase I–IV clinical trials across multiple therapeutic areas.
- Develop, validate, and maintain SDTM and ADaM datasets in accordance with CDISC standards and regulatory requirements.
- Design, develop, validate, and maintain complex SAS programs for clinical trial analysis and reporting.
- Generate Tables, Listings, and Figures (TLFs) for interim analyses, final analyses, clinical study reports, and regulatory submissions.
- Provide programming support for regulatory submissions, including FDA NDA, BLA, and IND applications.
- Develop and review analysis datasets, define.xml, annotated CRFs, and other regulatory submission-related documentation.
- Collaborate closely with Biostatisticians, Clinical Data Management, Clinical Operations, Medical Writing, and Regulatory Affairs teams.
- Participate in statistical analysis plan (SAP) reviews and provide programming input into analysis specifications.
- Perform independent QC and validation of statistical programs, datasets, and TLF outputs.
- Ensure compliance with CDISC, FDA, ICH, GCP, and internal sponsor programming standards.
- Troubleshoot complex programming issues and provide technical guidance to statistical programming teams.
- Support data review, data cleaning, database lock, and submission readiness activities.
- Manage programming deliverables, timelines, and quality expectations across multiple clinical studies.
- Participate in sponsor-side governance meetings and provide updates on programming progress, risks, and deliverables.
Requirements
- 10+ years of hands-on Statistical Programming experience within pharmaceutical or biotechnology sponsor organizations.
- Strong expertise in SAS Base, SAS Macro, SAS/STAT, PROC SQL, and advanced SAS programming.
- Extensive experience with CDISC SDTM and ADaM implementation.
- Strong understanding of CDISC implementation guides and regulatory submission standards.
- Expertise in developing and validating complex Tables, Listings, and Figures (TLFs).
- Experience with clinical trial data structures, analysis datasets, and statistical reporting.
- Strong knowledge of FDA regulatory submission requirements and electronic Common Technical Document (eCTD) deliverables.
- Experience with Define-XML, Pinnacle 21, and CDISC compliance validation.
- Expertise in clinical trial reporting, data review, and submission deliverables.
- Strong understanding of clinical development processes and clinical trial data standards.
- Direct employment or direct project experience within pharmaceutical or biotechnology sponsor organizations.
- Experience working on sponsor-owned clinical development programs.
- Direct collaboration with sponsor Biostatistics, Clinical Development, Clinical Data Management, and Regulatory teams.
- Ownership of statistical programming deliverables and submission activities.
- Experience supporting FDA regulatory submissions, including NDA/BLA packages.
- Ability to independently manage programming deliverables, timelines, and quality expectations.
Preferred Qualifications
- Experience in Oncology, Immunology, Hematology, Neurology, or Cardiovascular clinical trials.
- Experience supporting global Phase II and Phase III clinical development programs.
- Knowledge of R programming in addition to SAS.
- Experience with SAS Drug Development (SDD), SAS Life Science Analytics Framework (LSAF), or similar sponsor programming environments.
- Familiarity with Pinnacle 21 Enterprise and regulatory submission processes.
- Experience mentoring junior and mid-level statistical programmers.
Education
- Master's degree or PhD in Statistics, Biostatistics, Mathematics, Computer Science, or a related quantitative discipline.
- Equivalent industry experience may be considered.
See all 5,709+ H-1B Visa Programmer Analyst Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Programmer Analyst Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Programmer Analyst
Map your degree to the role
USCIS scrutinizes whether your specific degree field supports a Programmer Analyst title. A computer science or information systems degree maps cleanly, but a general business or unrelated degree can trigger an RFE even with years of relevant experience.
Search LCA filings by occupation code
Programmer Analyst falls under SOC code 15-1252. Use the OFLC Wage Search to filter certified LCA filings by that code and identify which employers filed petitions in your target metro, giving you a verified list of active H-1B sponsors.
Target employers enrolled in E-Verify
H-1B sponsorship requires employers to be registered with USCIS. Consulting firms and staffing agencies that place Programmer Analysts at client sites must also confirm they can serve as the H-1B petitioner, not just the end client.
Prioritize your job search on Migrate Mate
Filter Programmer Analyst openings by verified H-1B filing history using Migrate Mate. You can see which employers have active LCA certifications for this exact role, cutting out companies that won't sponsor before you invest time in applications.
Clarify the prevailing wage level before accepting
DOL assigns Programmer Analyst positions to wage levels 1 through 4. Your offered salary must meet the prevailing wage for your level and work location. Check the OFLC Wage Search for your metro to confirm the offer clears the threshold before signing.
Understand the cap-gap if you're on OPT
If your OPT expires before October 1 after a successful H-1B lottery selection, the cap-gap rule automatically extends your work authorization. Confirm with your employer that your start date and filing timeline account for this window so there's no gap in employment.
H-1B Visa Programmer Analyst: Frequently Asked Questions
Does a Programmer Analyst role qualify as an H-1B specialty occupation?
Yes, Programmer Analyst consistently qualifies as a specialty occupation under USCIS standards because the role normally requires at least a bachelor's degree in computer science, information systems, or a directly related technical field. The O*NET profile for this title confirms a degree requirement, which supports the specialty occupation determination USCIS applies during adjudication.
How do I find employers who sponsor H-1B visas for Programmer Analyst jobs?
Search Migrate Mate to find Programmer Analyst openings filtered by verified H-1B filing history. You can also cross-reference DOL LCA disclosure data by SOC code 15-1252 to see which companies have certified Labor Condition Applications for this title in your target location, confirming they've actively sponsored the role before.
Can a staffing agency or consulting firm sponsor my H-1B as a Programmer Analyst?
Yes, but the sponsoring employer must be the entity filing the H-1B petition, which creates complexity when you're placed at a client site. USCIS requires the petitioning employer to maintain an employer-employee relationship with you, including control over your work. Consulting firms that place Programmer Analysts must demonstrate this control to avoid denial on employer-employee relationship grounds.
What happens to my H-1B petition if my Programmer Analyst role changes significantly after approval?
Material changes to your job duties, work location, or employer can require an amended H-1B petition before the change takes effect. Moving to a new work site in a different metropolitan statistical area triggers a new LCA at minimum, and a significant shift in job duties away from the approved Programmer Analyst description may require a full amendment filed with USCIS.
How does the H-1B prevailing wage requirement apply to Programmer Analyst positions?
DOL sets prevailing wages for Programmer Analyst roles by geographic area and experience level, ranging from entry-level wage tier 1 to fully experienced tier 4. Your employer must certify on the LCA that your offered salary meets or exceeds the prevailing wage for your level and work location. Use the OFLC Wage Search to verify what the current prevailing wage is before evaluating any offer.