H-1B Visa Biostatistician Jobs
Biostatistician roles sit firmly within H-1B visa specialty occupation territory, requiring at least a master's degree in biostatistics, statistics, or a closely related field. Pharma, biotech, CROs, and academic medical centers are the heaviest sponsors. The cap-subject lottery applies unless your employer is a nonprofit research institution or university.
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The Lead Biostatistician is responsible for leading the development of statistical programs, performing complex analyses, and ensuring CRF and database design meet advanced analysis needs. Additionally, this role involves providing high-level statistical support across various departments, authoring comprehensive statistical analysis plans, and staying at the forefront of current statistical techniques.
This is an onsite position in San Diego, CA.
Essential Duties and Responsibilities
- Provides biostatistical expertise to Clinical Affairs staff; determines appropriate statistical methods and procedures.
- Works with other project team members in Clinical Affairs to ensure CRF and database design meets analysis needs.
- Develops statistical programs to perform statistical analysis and present results. Work with SAS programmers to ensure appropriate data analysis and presentation is performed.
- Provides input on Biostatistical and Data Management SOPs and work instructions. Recommends and implements continuous process improvement ideas.
- Writes statistical analysis plans (SAPs) and develops table/listing/graph shells for statistical analyses and reports.
- Interfaces with clinical investigators to determine protocol design.
- Writes the statistical and data analysis sections in regulatory submissions.
- Acts as a resource for other departments (e.g., R&D, QA, QC, Marketing, Manufacturing) regarding statistical issues including experimental design, sample size, statistical analysis and interpretation of results.
- Maintains expertise in current statistical analysis techniques and actively learns new techniques.
Required Qualifications and Experience
- Minimum MS in Statistics, Biostatistics, or related field (eg., Epidemiology)
- 3+ years (MS) or 1+ years (PhD) of progressive and relevant experience
- Working knowledge of CRF and database development, including attribute assignment and logic checking.
- Advanced knowledge of statistical software packages such as SAS, JMP or R.
- Knowledge of FDA regulatory requirements for IDE, BLA, PMA and 510K submissions.
- Advanced knowledge of applied statistical methods for clinical trials.
- Knowledge of applied statistical methods for design of experiments and quality control.
- Knowledge of infectious disease, cancer, genomics and common public health issues.
- Experience in technical writing.
The annualized base salary range for this hourly role is $102,500 to $160,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Why Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
If you have the right skills and experience, apply today!
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Join our dynamic team and make a lasting impact on patients’ lives through innovative clinical evidence.
The Lead Biostatistician is responsible for leading the development of statistical programs, performing complex analyses, and ensuring CRF and database design meet advanced analysis needs. Additionally, this role involves providing high-level statistical support across various departments, authoring comprehensive statistical analysis plans, and staying at the forefront of current statistical techniques.
This is an onsite position in San Diego, CA.
Essential Duties and Responsibilities
- Provides biostatistical expertise to Clinical Affairs staff; determines appropriate statistical methods and procedures.
- Works with other project team members in Clinical Affairs to ensure CRF and database design meets analysis needs.
- Develops statistical programs to perform statistical analysis and present results. Work with SAS programmers to ensure appropriate data analysis and presentation is performed.
- Provides input on Biostatistical and Data Management SOPs and work instructions. Recommends and implements continuous process improvement ideas.
- Writes statistical analysis plans (SAPs) and develops table/listing/graph shells for statistical analyses and reports.
- Interfaces with clinical investigators to determine protocol design.
- Writes the statistical and data analysis sections in regulatory submissions.
- Acts as a resource for other departments (e.g., R&D, QA, QC, Marketing, Manufacturing) regarding statistical issues including experimental design, sample size, statistical analysis and interpretation of results.
- Maintains expertise in current statistical analysis techniques and actively learns new techniques.
Required Qualifications and Experience
- Minimum MS in Statistics, Biostatistics, or related field (eg., Epidemiology)
- 3+ years (MS) or 1+ years (PhD) of progressive and relevant experience
- Working knowledge of CRF and database development, including attribute assignment and logic checking.
- Advanced knowledge of statistical software packages such as SAS, JMP or R.
- Knowledge of FDA regulatory requirements for IDE, BLA, PMA and 510K submissions.
- Advanced knowledge of applied statistical methods for clinical trials.
- Knowledge of applied statistical methods for design of experiments and quality control.
- Knowledge of infectious disease, cancer, genomics and common public health issues.
- Experience in technical writing.
The annualized base salary range for this hourly role is $102,500 to $160,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Why Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
If you have the right skills and experience, apply today!
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
See all 50+ H-1B Visa Biostatistician Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Biostatistician
Verify your degree meets specialty occupation
USCIS requires your degree field to directly relate to biostatistics work. A general mathematics or public health degree without quantitative coursework can trigger an RFE. Gather transcripts showing coursework in statistical theory, biostatistics methods, or clinical trial design before applying.
Target cap-exempt employers first
Nonprofit research hospitals, universities, and government-affiliated research centers can file your H-1B petition year-round with no lottery risk. CROs and pharma companies are cap-subject, so a contract role at a qualifying academic medical center sidesteps the lottery entirely.
Search LCA filing history on Migrate Mate
Filter by SOC code 15-2041 to see which employers have certified LCAs for Biostatistician roles. This shows you active sponsors before you spend time applying, not after you've already gone through interviews.
Align your job description to SOC code 15-2041
DOL classifies Biostatisticians under SOC 15-2041. Your offer letter and LCA must reflect duties matching that classification. Titles like 'Data Scientist' or 'Research Analyst' can create specialty occupation disputes if the listed responsibilities don't align with biostatistics methods.
Confirm prevailing wage tier before accepting an offer
Run your job title, location, and experience level through the OFLC Wage Search before negotiating. Your employer's LCA must certify wages at Level I through IV. Being underbid relative to your tier is a filing risk, not just a compensation issue.
Request premium processing for time-sensitive start dates
If you're transitioning off OPT or a contract ends, ask your prospective employer to file with USCIS premium processing. Standard adjudication timelines can stretch months, and a gap in authorization affects both you and the employer's clinical trial or study timelines.
H-1B Visa Biostatistician: Frequently Asked Questions
Does a Biostatistician role qualify as an H-1B specialty occupation?
Yes. USCIS consistently recognizes Biostatistician as a specialty occupation because the role normally requires at least a bachelor's degree, and in practice most employers require a master's or doctorate in biostatistics or statistics. Your offer letter and supporting documentation should make the degree requirement explicit, not just preferred.
Which industries sponsor H-1B visas most often for Biostatisticians?
Pharmaceutical companies, contract research organizations, academic medical centers, and federal health agencies are the most consistent sponsors. You can confirm which specific employers have active LCA filings for biostatistics roles by searching Migrate Mate, which surfaces DOL Labor Condition Application data filtered by occupation code.
Can a Biostatistician avoid the H-1B lottery?
If your employer is a nonprofit research institution, university, or government research entity, your petition is cap-exempt and bypasses the lottery entirely. Roles at private CROs or pharma companies are cap-subject. Some candidates secure a cap-exempt position first to obtain H-1B status, then transfer to a cap-subject employer later.
What happens to my H-1B if my clinical trial project ends early?
Your H-1B status is employer-specific and project-independent. If your employer terminates your position, you have a 60-day grace period to find a new sponsor, change status, or depart. The employer is also obligated to cover reasonable costs of your return transportation to your home country under DOL regulations.
Does a master's in public health or epidemiology qualify for a Biostatistician H-1B?
It depends on the coursework. USCIS evaluates whether your degree directly relates to the duties in the petition. A public health or epidemiology degree with substantial graduate-level biostatistics or statistical methods coursework can qualify, but a credential without that coursework may require a credential evaluation or supplemental documentation to satisfy the specialty occupation requirement.