H-1B Visa Systems Programmer Jobs
Systems Programmer roles sit squarely within H-1B visa specialty occupation territory, requiring a bachelor's degree or higher in computer science, software engineering, or a closely related field. Employers filing H-1B petitions for this role must certify prevailing wage compliance through a DOL Labor Condition Application before USCIS can approve the petition.
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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 5,699+ H-1B Visa Systems Programmer Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Systems Programmer
Match your degree to the role title
USCIS scrutinizes whether your specific degree field directly supports a Systems Programmer position. A degree in computer science or software engineering strengthens your petition. A general IT or business degree may trigger a Request for Evidence.
Use O*NET to anchor your job duties
Pull the O*NET occupation profile for Systems Programmer before interviews. Employers need your job duties statement to align with the specialty occupation definition, and referencing that profile helps both sides build a petition USCIS won't challenge.
Target employers with cap-exempt filing history
Universities, nonprofit research institutions, and government-affiliated entities are exempt from the H-1B cap lottery. Systems Programmer roles exist at these organizations, and a cap-exempt petition can be filed any time of year without waiting for April registration.
Find verified H-1B sponsors on Migrate Mate
Search Systems Programmer roles on Migrate Mate to surface employers with confirmed H-1B Labor Condition Application filing history from DOL disclosure data, so you're applying to companies that have already navigated the sponsorship process for this role type.
Verify prevailing wage tier before accepting an offer
Your employer's LCA must certify wages at or above the DOL prevailing wage for your geographic area and experience level. Run the OFLC Wage Search yourself before negotiating an offer to confirm the employer isn't filing at a tier below your market rate.
Clarify petition filing timing relative to your start date
Standard H-1B petitions for cap-subject roles take three to six months to adjudicate. If your OPT or grace period is running short, ask your employer whether premium processing, which USCIS typically decides within 15 business days, is on the table.
H-1B Visa Systems Programmer: Frequently Asked Questions
Does a Systems Programmer role qualify as an H-1B specialty occupation?
Yes, Systems Programmer qualifies as a specialty occupation under H-1B rules because the position normally requires at least a bachelor's degree in computer science, software engineering, or a directly related field. USCIS evaluates both the job duties and the degree requirement. If your employer's job description lists a broad range of acceptable majors or frames the degree as preferred rather than required, that can weaken the specialty occupation argument and invite a Request for Evidence.
Can I switch employers while on an H-1B as a Systems Programmer?
Yes. Under H-1B portability rules, you can start working for a new employer as soon as they file an H-1B transfer petition with USCIS, provided your current status is valid and the new role is in the same or a similar occupational classification. You don't need to wait for final approval before starting. The new employer still needs to file a certified LCA and a Form I-129 with USCIS before your first day.
How do I find Systems Programmer jobs with confirmed H-1B sponsorship?
Search Systems Programmer roles on Migrate Mate, which surfaces employers with verified H-1B Labor Condition Application filing history drawn directly from DOL disclosure data. This filters out job listings where sponsorship is theoretical or case-by-case, showing you only employers who have gone through the LCA certification process for roles in this occupational category.
What documentation should I prepare before a Systems Programmer H-1B petition?
Your employer's attorney will need your official degree transcripts, diploma, and any foreign credential evaluation if your degree was issued outside the U.S. For Systems Programmer roles, a detailed technical resume that maps your experience to low-level programming, operating systems, or systems architecture is especially useful. If your degree is in a loosely related field, letters from former supervisors documenting relevant systems-level work can support the specialty occupation argument.
Does remote work affect my H-1B status as a Systems Programmer?
Remote work can affect your H-1B because the LCA is tied to a specific worksite location. If you move to a different metropolitan statistical area than what's listed on the certified LCA, your employer must file an amended LCA and potentially an amended H-1B petition before you begin working from that location. USCIS and DOL have both issued guidance on this, so confirm your employer's process before relocating, even temporarily.