Fiscal Year

2024

Case Number

A-23110-30823

Case Status

Certified

Received Date

2023-05-15

Decision Date

2024-06-05

Refile

N

Original File Date

2024-01-01 01:37:23

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

EDWARDS LIFESCIENCES LLC

Employer Name Slug

edwards-lifesciences-llc

Employer Address 1

ONE EDWARDS WAY

Employer Address 2

Employer City

IRVINE

Employer City Slug

irvine

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

92614

Employer Phone

(949) 250-6338

Employer Number of Employees

17300

Employer Year Commenced Business

2000

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Diana Fernando

Employer Contact Address 1

ONE EDWARDS WAY

Employer Contact Address 2

Employer Contact City

IRVINE

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

92614

Employer Contact Phone

(949) 250-2350

Employer Contact Email

Diana_Fernando@edwards.com

Agent Attorney Name

Diana V Coker

Agent Attorney Firm Name

Larrabee Albi Coker LLP

Agent Attorney Phone

(858) 642-0420

Agent Attorney Address 1

P.O. Box 919016

Agent Attorney Address 2

Agent Attorney City

San Diego

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

92191-9016

Agent Attorney Email

Diana@larrabee.com

PW Track Number

P10022217400720

PW SOC Code

15-2041.01

PW SOC Title

Biostatisticians

PW Skill Level

Level II

PW Wage

88858.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2023-02-15

PW Expiration Date

2023-06-30

Wage Offer From

124900.00

Wage Offer To

177240.00

Average Salary

151070.00

Wage Unit of Pay

Year

Worksite Address 1

One Edwards Way

Worksite Address 2

Worksite City

Irvine

Worksite City Slug

irvine

Worksite State

CALIFORNIA

Worksite Postal Code

92614

Job Title

Sr. Biostatistician

Job Title Slug

sr-biostatistician

Minimum Education

Master's

Major Field of Study

Statistics, Biostatistics or a related field

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

See H.4B.

Accept Alternative Combination

Y

Accept Alternative Combination Education

Doctorate

Accept Alternative Combination Education Years

0

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

24

Accept Alternative Job Title

statistical analytical experience in clinical trials contd in H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Contd from H.8 In lieu of a Masters degree and 2 years of experience, employer will accept a PhD degree or equivalent in Statistics, Biostatistics or a related field.br br Contd from H.10B to include any relevant job titles within this occupation.br br Contd from H.12 Job requirements are normal for the employer due to the complexity of job duties associated with this position. Employer answered no to Question H.12 based on SVP analysis only.br br Work experience to include 1. SAS programming. 2. Utilizing R or SPlus software packages. 3. Applying theoretical and applied statistics to perform statistical testing, generate outputs, and validate the tables, listings, and figures for Premarket Application. 4. Working with regulatory guidelines GP and FDA as they apply to a pharmaceutical or medical device research setting. 5. Developing Statistical Analysis Plans SAP and supporting the statistical execution effort for clinical studies. 6. Developing statistical programs to ensure the accuracy of the planned and completed analyses or exploratory analyses. 7. Reviewing protocols, contributing to protocol statistical analysis sections, and generating study randomization schema. 8. Authoring results sections of the Clinical Study Reports CSR and supplying statistical input for premarket approval submissions and in response to regulatory questions. 9. Providing independent validation of the statistical content in study documents including randomization, study reports, briefing documents, patient brochures, and publications delivered to external entities. 10. Keeping abreast of new developments in statistics, device development, and regulatory guidance. 11. Developing case report forms and clinical database and performing data cleaning to ensure quality data selection. The employer will accept academic background with the listed skills from the applicants with PhD degree.br Hiring Requirements Drug TestingScreening, Background Checks.

Combination Occupation

N

Offered to Applicant Foreign Worker

Y

Foreign Worker Live on Premises

N

Foreign Worker Live in Domestic Service

N

Foreign Worker Live in Domestic Service Count

Professional Occupation

Y

Application for College/University Teacher

N

SWA Job Order Start Date

2023-01-24

SWA Job Order End Date

2023-02-24

Sunday Edition Newspaper

Y

First Newspaper Name

Orange County Register

First Advertisement Start Date

2023-03-05

Second Newspaper Ad Name

Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2023-03-12

Employer Website From Date

2024-01-01 01:37:23

Employer Website To Date

2024-01-01 01:37:23

Professional Organization Ad From Date

2024-01-01 01:37:23

Professional Organization Advertisement To Date

2024-01-01 01:37:23

Job Search Website From Date

2023-03-06

Job Search Website To Date

2023-03-12

Employee Referral Program From Date

2024-01-01 01:37:23

Employee Referral Program To Date

2024-01-01 01:37:23

Local Ethnic Paper From Date

2023-03-06

Local Ethnic Paper To Date

2023-03-06

Radio/TV Ad From Date

2024-01-01 01:37:23

Radio/TV Ad To Date

2024-01-01 01:37:23

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

CHINA

Foreign Worker Birth Country

CHINA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

BIOSTATISTICS

Foreign Worker Years of Education Completed

2018

Foreign Worker Institution of Education

UNIVERSITY OF PENNSYLVANIA

Foreign Worker Education Institution Address 1

3535 MARKET STREET

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

PHILADELPHIA

Foreign Worker Education Institution State/Province

PA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

19104

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Diana V Coker

Preparer Title

Partner Attorney at Law

Preparer Email

Diana@larrabee.com

Employer Information Declaration Name

Tracie M Pham

Employer Information Declaration Title

Sr. Talent Mobility Specialist