Fiscal Year

2022

Case Number

A-21312-69344

Case Status

Denied

Received Date

2021-12-14

Decision Date

2022-07-28

Refile

N

Original File Date

2022-01-01 11:47:36

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) 250-3444

Employer Number of Employees

15000

Employer Year Commenced Business

2000

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Tracie Pham

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) 250-3444

Employer Contact Email

Tracie_Pham@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

P10021092195184

PW SOC Code

15-2041

PW SOC Title

Statisticians

PW Skill Level

Level I

PW Wage

63606.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-09-03

PW Expiration Date

2022-06-30

Wage Offer From

101500.00

Wage Offer To

0.00

Average Salary

101500.00

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

Biostatistician

Job Title Slug

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

N

Accept Alternative Major Field of Study

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

12

Accept Alternative Job Title

SAS programming, statistical analysis or a combination of these fields

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Work experience to include 1. Utilizing SAS and R to perform statistical testing, and to generate outputs; and to validate the tables, listings, and figures for Premarket Application. 2. Theoretical and applied statistics. 3. Working with regulatory guidelines including Good Clinical Practice and FDA as they apply to a pharmaceutical or medical device research setting. 4. Using MS Word to write the statistical analysis section of the protocol including mathematical formula for hypothesis testing. 5. Using Excel to record data issues and to review data using filters and statistical functions and to write the specification for analysis dataset. 6. Using PowerPoint to present statistical analysis results to management. 7. Utilizing SAS to perform statistical analysis, data processing, and exploration; must include SAS macro, SAS SQL, SASSTAT, and data step programming. 8. Working on at least one project using Bayesian statistics. 9. Communicating statistical concepts to statisticians and nonstatisticians. 10. Creating analysis data sets specifications and programs, tables, listings and graphs and interpreting statistical analyses and summary statistics. 11. Working with Data Management, Clinical Affairs, Regulatory Affairs and Scientific Communications to create final work product. 12. Performing statistical analysis for clinical data in SASBASE and SASSTAT. 13. Validating work produced by other programmers. 14. Support statistical aspects of clinical trial life cycle. 15. Working with regulatory requirements governing industry technical standards, including CDISC, 23 CFR Part 11 and electronic FDA submissions. 16. Conducting statistical analysis for clinical trials.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

2021-07-12

SWA Job Order End Date

2021-08-12

Sunday Edition Newspaper

Y

First Newspaper Name

Orange County Register

First Advertisement Start Date

2021-08-08

Second Newspaper Ad Name

Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-08-15

Employer Website From Date

2022-01-01 11:47:36

Employer Website To Date

2022-01-01 11:47:36

Professional Organization Ad From Date

2022-01-01 11:47:36

Professional Organization Advertisement To Date

2022-01-01 11:47:36

Job Search Website From Date

2021-08-09

Job Search Website To Date

2021-08-14

Employee Referral Program From Date

2022-01-01 11:47:36

Employee Referral Program To Date

2022-01-01 11:47:36

Local Ethnic Paper From Date

2021-08-09

Local Ethnic Paper To Date

2021-08-09

Radio/TV Ad From Date

2022-01-01 11:47:36

Radio/TV Ad To Date

2022-01-01 11:47:36

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

F-1

Foreign Worker Education

Master's

Foreign Worker Information: Major

BIOSTATISTICS

Foreign Worker Years of Education Completed

2017

Foreign Worker Institution of Education

UNIVERSITY OF CALIFORNIA, LOS ANGELES

Foreign Worker Education Institution Address 1

650 CHARLES E. YOUNG DRIVE SOUTH

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

LOS ANGELES

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

90095

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

PartnerAttorney at Law

Preparer Email

Diana@larrabee.com

Employer Information Declaration Name

Heather Sheira

Employer Information Declaration Title

Sr. Manager, Global Mobility