Fiscal Year

2023

Case Number

A-22013-97416

Case Status

Certified

Received Date

2022-03-01

Decision Date

2022-11-21

Refile

N

Original File Date

2023-01-01 18:09:21

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ASTRAZENECA PHARMACEUTICALS LP

Employer Name Slug

astrazeneca-pharmaceuticals-lp

Employer Address 1

1800 CONCORD PIKE

Employer Address 2

Employer City

WILMINGTON

Employer City Slug

wilmington

Employer State

DELAWARE

Employer State Slug

delaware

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

19897

Employer Phone

302-886-3000

Employer Number of Employees

76100

Employer Year Commenced Business

1966

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Echeverri Adriana

Employer Contact Address 1

One MedImmune Way

Employer Contact Address 2

Employer Contact City

Gaithersburg

Employer Contact State/Province

MARYLAND

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

20878

Employer Contact Phone

301-398-0209

Employer Contact Email

adriana.echeverri@astrazeneca.com

Agent Attorney Name

Hyla K Rosenberg

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy LLP

Agent Attorney Phone

2126888555

Agent Attorney Address 1

1400 Broadway

Agent Attorney Address 2

Agent Attorney City

New York

Agent Attorney State/Province

NEW YORK

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

10018

Agent Attorney Email

svialva@fragomen.com

PW Track Number

P10021162391745

PW SOC Code

13-1041

PW SOC Title

Compliance Officers

PW Skill Level

Level IV

PW Wage

106974.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-11-18

PW Expiration Date

2022-06-30

Wage Offer From

141000.00

Wage Offer To

0.00

Average Salary

141000.00

Wage Unit of Pay

Year

Worksite Address 1

101 Orchard Ridge Drive

Worksite Address 2

Worksite City

Gaithersburg

Worksite City Slug

gaithersburg

Worksite State

MARYLAND

Worksite Postal Code

20878

Job Title

Statistical Programming Associate Director (Principal Programming Leader)

Job Title Slug

statistical-programming-associate-director-principal-programming-leader

Minimum Education

Bachelor's

Major Field of Study

Pharmaceutical Sciences, Regulatory Affairs or related field

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

3

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

Clinical Data Analyst or in a related role.

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must have a Bachelors degree or foreign equivalent in Pharmaceutical Sciences, Regulatory Affairs or related field of study plus five 5 years of progressively responsible experience in the offered role, as a Clinical Data Analyst or in a related role. Must have five 5 years of progressively responsible experience with all of the following within the pharmaceutical industry Supporting regulatory submissions including specification and delivery of overview databases, outputs and responses to regulatory questions by applying knowledge of technical and regulatory requirements relating to clinical trials and submission across therapeutic area; Implementing Clinical trial protocol and Statistical Analyses plans into fully documented and tested SAS Statistical Analysis Software programs supporting both safety and efficacy displays and Analysis Data sets required for a clinical trial report; Guiding and managing electronicbr submissions to FDA Food Drug Administration, and other regulatory agencies worldwide; Performing validation to ensure the quality of the submission by applying regulatory standards including FDA, CHMP Committee for Medicinal Products for Human Use, PMDA Pharmaceuticals and Medical Device Agency, ICH International Council for Harmonization, and GCPbr Good Clinical Practice; Facilitating and managing the design and creation of regulatory and CDISC Clinical Data Interchange Standards Consortium compliant system to conduct clinical trials in accordance with CDSIC standards; Developing regulatory compliant processes and systems, analyzing complex clinical trials data, creating reporting algorithms, and preparingbr supporting technical documents required by FDA; and Developing and validating SAS programs to perform statistical analysis supporting regulatory request, publicationcommercial requests and adhoc analyses. In the alternative, the employer will accept a Masters degree in a stated field of study plus three 3 years of experience. Employer will accept pre or post MA degree experience. Any combination of education, experience or training is acceptable.

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

2021-12-01

SWA Job Order End Date

2022-01-03

Sunday Edition Newspaper

Y

First Newspaper Name

The Washington Post

First Advertisement Start Date

2021-12-12

Second Newspaper Ad Name

The Washington Post

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-12-19

Employer Website From Date

2021-11-04

Employer Website To Date

2022-02-02

Professional Organization Ad From Date

2023-01-01 18:09:21

Professional Organization Advertisement To Date

2023-01-01 18:09:21

Job Search Website From Date

2021-12-12

Job Search Website To Date

2021-12-27

Employee Referral Program From Date

2021-09-30

Employee Referral Program To Date

2021-10-15

Local Ethnic Paper From Date

2021-12-15

Local Ethnic Paper To Date

2021-12-15

Radio/TV Ad From Date

2023-01-01 18:09:21

Radio/TV Ad To Date

2023-01-01 18:09:21

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

INDIA

Foreign Worker Birth Country

INDIA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

REGULATORY AFFAIRS FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES

Foreign Worker Years of Education Completed

2016

Foreign Worker Institution of Education

NORTHEASTERN UNIVERISTY

Foreign Worker Education Institution Address 1

360 HUNTINGTON AVE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BOSTON

Foreign Worker Education Institution State/Province

MA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

2115

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Hyla K Rosenberg

Preparer Title

Partner

Preparer Email

svialva@fragomen.com

Employer Information Declaration Name

Adriana Echeverri

Employer Information Declaration Title

International Experiences, Regional Lead NA