Fiscal Year

2023

Case Number

A-22137-56324

Case Status

Certified

Received Date

2022-06-14

Decision Date

2023-02-17

Refile

N

Original File Date

2023-01-01 08:06:34

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Apellis Pharmaceuticals, Inc.

Employer Name Slug

apellis-pharmaceuticals-inc

Employer Address 1

100 Fifth Avenue

Employer Address 2

Floor 3

Employer City

Waltham

Employer City Slug

waltham

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2451

Employer Phone

6179775700

Employer Number of Employees

485

Employer Year Commenced Business

2009

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Brian Jochim

Employer Contact Address 1

100 Fifth Avenue

Employer Contact Address 2

Floor 3

Employer Contact City

Waltham

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2451

Employer Contact Phone

6179775700

Employer Contact Email

brian.jochim@apellis.com

Agent Attorney Name

John J Gallini

Agent Attorney Firm Name

Parker Gallini LLP

Agent Attorney Phone

7818108990

Agent Attorney Address 1

400 Fifth Avenue

Agent Attorney Address 2

Suite 401

Agent Attorney City

Waltham

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2451

Agent Attorney Email

jgallini@parkergallini.com

PW Track Number

P10021159379747

PW SOC Code

15-2041

PW SOC Title

Statisticians

PW Skill Level

Level IV

PW Wage

140192.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-11-15

PW Expiration Date

2022-06-30

Wage Offer From

192000.00

Wage Offer To

0.00

Average Salary

192000.00

Wage Unit of Pay

Year

Worksite Address 1

100 Fifth Avenue

Worksite Address 2

Floor 3

Worksite City

Waltham

Worksite City Slug

waltham

Worksite State

MASSACHUSETTS

Worksite Postal Code

2451

Job Title

Associate Director, Statistical Programming

Job Title Slug

associate-director-statistical-programming

Minimum Education

Bachelor's

Major Field of Study

Computer Science

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Statistics, Information Science or a closely related Life Science field

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

96

Accept Alternative Job Title

See H.14

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Bachelors degree in Computer Science, Statistics, Information Science or a closely related Life Science fieldbr 8 years of experience in a statistical programming role supporting clinical trials in the pharmaceutical industry.br br Qualifying experience which may have been gained concurrently must include the followingbr br 8 years of experience with SAS software, which must includebr o SAS Enterprise Guide Studio, SASBase, SASSQL, SASMacro, SASGraph, SASODS, and SASSTATbr br 6 years of experience preparation of CDISC compliant SDTMADAM specifications, programming quality control plan, analysis datasets programming, and tables, listings, and graphs generation in accordance with 21 CFR Part 11br br 4 years of experience as a Statistical Programming Lead and covering the followingbr o regulatory submissions sNDA, including Integrated Summary of Safety and Efficacy ISSISE, safety updates, and adhoc requests from agencies FDA, EMEAbr o leading statistical programming efforts across different protocols and submission activities and working cross functionally with Biostatistics, Data Management, Clinical Operations, Clinical Development groups, andbr o providing recommendations for maintenance and development of SP global policies and proceduresbr br 2 years of experience with the following office tools Adobe Acrobat Professional, MS Projectbr br Qualified candidates for consideration will be expected to have the following skills, knowledge abilitiesbr English language fluency oral and writtenbr Indepth knowledge and understanding of global clinical trial practices, procedures, methodologies and data presentationbr Indepth knowledge and understanding of regulatory requirements relevant to SP e.g. CGP, ICH, Computerized System Validationbr Operational management skills, and proven ability to supervise others and ensure delivery by teambr br br From H.10B., Job title of the acceptable alternate occupation experience in a statistical programming role supporting clinical trials in the pharmaceutical industry.

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

2022-01-12

SWA Job Order End Date

2022-02-16

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Globe

First Advertisement Start Date

2022-01-23

Second Newspaper Ad Name

Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-01-30

Employer Website From Date

2022-01-20

Employer Website To Date

2022-02-04

Professional Organization Ad From Date

2023-01-01 08:06:34

Professional Organization Advertisement To Date

2023-01-01 08:06:34

Job Search Website From Date

2022-01-20

Job Search Website To Date

2022-01-27

Employee Referral Program From Date

2023-01-01 08:06:34

Employee Referral Program To Date

2023-01-01 08:06:34

Local Ethnic Paper From Date

2022-01-24

Local Ethnic Paper To Date

2022-01-26

Radio/TV Ad From Date

2023-01-01 08:06:34

Radio/TV Ad To Date

2023-01-01 08:06:34

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

DECISION AND INFORMATION SCIENCE

Foreign Worker Years of Education Completed

2007

Foreign Worker Institution of Education

THE UNIVERSITY OF FLORIDA

Foreign Worker Education Institution Address 1

222 CRISER HALL

Foreign Worker Education Institution Address 2

BOX 114000

Foreign Worker Education Institution City

GAINESVILLE

Foreign Worker Education Institution State/Province

FL

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

32611

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

John J Gallini

Preparer Title

Attorney

Preparer Email

jgallini@parkergallini.com

Employer Information Declaration Name

Brian Jochim

Employer Information Declaration Title

Sr. Director, Talent Acquisition