u/travelmom_0201

Considering EB2 NIW and would appreciate feedback on my profile. I'm already working with an attorney but want a sanity check from this community before filing.
Background
PharmD + MS Biostatistics. Currently serving as primary biostatistician on NIH- and DoD-funded multicenter clinical trials. Active therapeutic areas include chronic pain (NIH HEAL Initiative), sickle cell disease, intracerebral hemorrhage, and Alzheimer's disease.
Research record
11 peer-reviewed publications, including work in NEJM, JAMA, and Clinical Infectious Diseases
525 citations across all work, h-index [11]
21 peer review invitations from [2–3 representative journals impact factor 3 to 8 ]
Contributed to the evidence base supporting FDA EUA expansion and the subsequent Biologics License Application pathway for COVID-19 convalescent plasma — a documented change in national clinical practice
Two projects recognized in the Clinical Research Forum Top 10 / Top 20
Technical scope on active trials
Statistical analysis plans, randomization and power calculations, DSMB reporting, missing data methodology, PK/PD analyses, and longitudinal regulatory-grade modeling for biologics, neurological disorders, infectious diseases, and chronic pain therapies.
Forward-looking work
Beyond conventional trial support, I work on modernizing U.S. clinical trial infrastructure — specifically AI-assisted trial workflows, decentralized trial design, and pharmacometrics methods that improve evidence quality and accelerate access to therapies for high-risk populations.

Questions for the community
Does this profile appear strong for EB2 NIW under the Dhanasar framework?
Major weaknesses you'd flag before filing?
How critical are independent recommendation letters for a profile like this (my attorney offered 0, 2, or 4 letters as options)?
Given the regulatory-impact and FDA-guidance angle, is EB1A worth pursuing concurrently?
Thanks in advance.

Hi everyone,
I’m considering applying for EB1A and would appreciate feedback on how competitive my profile is.
Background:
PharmD + MS Biostatistics
Currently working in U.S. multicenter clinical trials and biostatistics
Also pursuing MS in Pharmacometrics
Working on NIH-, DoD-, and federally funded Phase 2/3 clinical trials
Profile summary:
20+ peer-reviewed publications
Publications in high-impact journals including:
NEJM
JAMA
Clinical Infectious Diseases
300+ citations on a major COVID-19 outpatient convalescent plasma publication
Served in key operational and biostatistical roles in multicenter national clinical trials
Major FDA / regulatory impact:
Contributed to the national outpatient COVID-19 convalescent plasma trials (CSSC-004/CSSC-001)
Trial evidence contributed to the FDA expansion of Emergency Use Authorization (EUA) for high-titer COVID-19 convalescent plasma for outpatient immunocompromised patients
Research findings were incorporated into national treatment guideline updates from infectious disease organizations
Trial evidence later contributed to the first FDA Biologics License Application (BLA) approval for COVID-19 convalescent plasma in the U.S.
Work supported transition of convalescent plasma from emergency authorization to fully licensed biologic therapy
Participated in development of decentralized investigational product infrastructure and regulatory-compliant blood product coordination systems used across national trial sites
Current and ongoing work:
Primary/lead biostatistician on NIH-funded multicenter trials involving:
Chronic pain / NIH HEAL Initiative
Sickle cell disease
Intracerebral hemorrhage
Alzheimer’s disease
Responsibilities include:
Statistical analysis plans
Randomization methodology
DSMB reporting
Missing data strategy
Longitudinal modeling
PK/PD analyses
Regulatory-grade clinical trial analyses
Additional points:
Clinical Research Forum Top 10 / Top 20 recognized projects
Experience supporting trials with tens of millions in federal funding
Contributions to decentralized and AI-assisted clinical trial infrastructure
Working on increasing peer review/judging activities
Potential EB1A criteria:
Scholarly articles
Original contributions of major significance
Critical role for distinguished organizations/projects
Published material
Judging/reviewer activities (developing further)
Would appreciate feedback on:
Whether this profile appears competitive for EB1A currently
Main weaknesses USCIS may focus on
Importance of independent citations vs authorship
Whether more reviewing/judging activity is needed before filing
Thanks in advance.