H-1B Visa Senior Statistical Programmer Jobs
Senior Statistical Programmer roles sit squarely within H-1B visa specialty occupation territory, requiring a bachelor's degree or higher in statistics, biostatistics, or a related quantitative field. Pharma, biotech, and CRO employers file LCAs through DOL before sponsoring, and most treat H-1B fees as a standard cost of hiring specialized clinical trial talent.
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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 32+ H-1B Visa Senior Statistical Programmer Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Senior Statistical Programmer Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Senior Statistical Programmer
Align your degree to SOC codes
USCIS evaluates specialty occupation fit by matching your degree field to the role's SOC code. For Senior Statistical Programmers, confirm your transcript reflects statistics, biostatistics, mathematics, or computer science before any employer files your petition.
Target employers with active LCA filings
Use Migrate Mate to filter Senior Statistical Programmer roles by verified DOL LCA history. Employers with recent filings in this occupation have already cleared the prevailing wage certification step, signaling a practiced H-1B sponsorship process.
Request SAS and CDISC credentials before applying
Pharma and CRO sponsors frequently specify CDISC SDTM and ADaM standards alongside SAS certification in LCA job descriptions. Holding documented credentials strengthens the specialty occupation argument USCIS reviews when adjudicating your I-129.
Verify the prevailing wage before negotiating
Run your target job title and work location through the OFLC Wage Search before entering salary discussions. Your employer must pay at least the DOL prevailing wage, and knowing the Level II or III threshold prevents offers that would fail LCA certification.
Confirm cap-exempt status for academic medical centers
Universities, nonprofit research organizations, and affiliated teaching hospitals are cap-exempt employers. If you're pursuing a Senior Statistical Programmer role at an academic medical center, H-1B sponsorship isn't subject to the annual 85,000-slot lottery and can start any time of year.
Use the 60-day grace period strategically
If your current H-1B ends due to a layoff, USCIS allows a 60-day grace period to secure a new sponsoring employer. Prioritize pharma and biotech companies actively filing LCAs so your next employer can submit an I-129 transfer petition before the window closes.
H-1B Visa Senior Statistical Programmer: Frequently Asked Questions
Does a Senior Statistical Programmer role qualify as a specialty occupation for H-1B purposes?
Yes. USCIS classifies Senior Statistical Programmer positions as specialty occupations because the role normally requires at least a bachelor's degree in statistics, biostatistics, mathematics, or a closely related field. The O*NET profile for this occupation confirms the degree requirement, which is a primary factor in USCIS's specialty occupation determination during I-129 adjudication.
Which industries sponsor H-1B visas most often for this role?
Pharmaceutical companies, contract research organizations, and biotech firms account for the large majority of H-1B LCA filings for Senior Statistical Programmer positions. Academic medical centers and government-affiliated research institutions also sponsor but are often cap-exempt, meaning they can file year-round without lottery selection. You can browse employers with verified filing histories on Migrate Mate.
How does the H-1B prevailing wage requirement affect Senior Statistical Programmer offers?
Before filing your LCA, your employer must certify to DOL that your offered wage meets or exceeds the prevailing wage for your job title and work location. For Senior Statistical Programmer roles, the wage level depends on experience and geographic market. You can verify applicable wage levels using the OFLC Wage Search before accepting or negotiating any offer.
Can a Senior Statistical Programmer transfer their H-1B to a new employer mid-project?
Yes. H-1B portability under AC21 lets you start working for a new sponsoring employer as soon as they file an I-129 transfer petition, without waiting for approval, provided your current H-1B is valid and you've maintained status. Clinical trial timelines don't pause H-1B transfers, so coordinating the petition timing around project milestones is straightforward.
What documents should a Senior Statistical Programmer prepare before an employer files the H-1B petition?
You'll need official transcripts showing a qualifying degree, a current resume mapping your programming experience to the specific role, and documentation of any relevant certifications such as SAS or CDISC credentials. If your degree is from outside the U.S., a credential evaluation from a NACES-member organization strengthens the specialty occupation argument USCIS reviews when adjudicating the I-129.