Agent/ Attorney Address Line 1:2 Seaport Lane Seaport East
Agent/ Attorney Address Line 2:Suite 300
Agent/ Attorney City:Boston
Agent/ Attorney State/ Province:MASSACHUSETTS
Agent/ Attorney Country:UNITED STATES OF AMERICA
Agent/ Attorney Postal Code:2210
Agent/ Attorney Email:ddelvecchio@seyfarth.com
Position Info
Prevailing Wage Track Number:P10020357975551
Prevailing Wage SOC Code :15-2041
Prevailing Wage SOC Title :Biostatisticians
Prevailing Wage Skill Level:N/A
Prevailing Wage:66500
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:Other
Prevailing Wage Other Source:The Survey Group: Benchmark Compensation Survey
Prevailing Wage Determination Date :2021-07-13
Prevailing Wage Expiration Date :2022-06-30
Wage Offer From:128750
Wage Offer To:140192
Wage Offer Unit of Pay:Year
Workstie Address Line 1:150 Second Street
Worksite Address Line 2:
Worksite City :Cambridge
Worksite State:MASSACHUSETTS
Worksite Postal Code:2141
Job Title:Senior Biostatistician
Minimum Education:Master's
Other Degree/ Diploma:
Major Field of Study:Biostatistics, Epidemiology
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :N
Required Expreience Months :
Accept Alternate Field of Study:Y
Accept Alternate Major:Statistics, or a closely related field
Alternate Combination of Education/ Experience:N
Required Alternate Level of Education :
Other Alternate Level of Education:
Acceptable Years of Experience:
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:24
Accept Alternate Job Title:Job offered or experience leading the statistical effort for Next CONTD IN H.14
Normal Requirements of Job Opportunity:N
Required Foreign Language:N
Specific Skills:CONTD FROM H.10B Generation Sequencing NGS based companion diagnostic CDx assays development.br br Education and Experiencebr br Masters degree or foreign education equivalent in Biostatistics, Epidemiology, Statistics, or a closely related field and two 2 years experience in the job offered or two 2 years experience leading the statistical effort for Next Generation Sequencing NGS based companion diagnostic CDx assays development.br br Skills and Knowledgebr br Candidate must also possessbr br Demonstrated Expertise DE managing and executing analytical and clinical validation studies; and conducting complex disease research or cancer drug and device development projects in collaboration with diverse functions biostatistics, program and alliance management, development operations, quality assurance QA, and franchise;br br DE developing drug or medical devices for cancer patients, using NGS technology for key analytical or clinical components of regulatory submissions Requests for Feedback on Medical Device Submissions Qsubs, PreMarketing Approval PMA, and supplemental PreMarketing Approval sPMA; and reviewing device changes, verifications, and validations using mechanisms Operational Qualifications OQ, Performance Qualifications PQ, and Design Controls;br br DE developing study protocols, statistical analysis plans, data reports, and clinical trial documentation for drug or medical devices; soliciting feedback and communicating study resultssummaries of accuracy, limit of detection, and precision and clinical bridging study results which will be included in Summary of Safety and Efficacy Documents posted by the FDA on their website to the public to external stakeholders;br br DE preparing U.S. Food and Drug Administration FDA submissions and communications for the Center for Drug Evaluation and Research CDER or the Center for Devices and Radiological Health CDRH; and applying FDA regulations for drug or medical device development, marketing applications, regulatory approval, and clearance of oncological companion diagnostic assays.br br Domestic travel is required 20 of the time to attend FDA meetings in Washington, DC, to meet biopharma companies for projects, and attend conferences.
Combination Occupation :N
Offered to Applied Foreign Worker:Y
ForeignWorker Live on Premises :N
Live in Domestic Service Worker:N
Employment Contract :
Professional Occupation :Y
College/ University Teacher:N
Competitive Process:
Basic Recruitment Process :
Teacher Select Date:
Teacher Publish Journal Name:
Additional Recruitment Information:
Job Oder Start Date:2021-07-20
Job Oder End Date:2021-08-24
Sunday Edition Newspaper:Y
First Newspaper Name:The Boston Globe
First Advertisement Start Date:2021-08-08
Second Newspaper Name:The Boston Globe
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-08-15
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:
Employer Website to Date:
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:
Job Search Website to Date:
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:2021-07-21
Employee Referral Program to Date:2021-08-09
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:2021-08-09
Local Ethnic Newspaper to Date:2021-08-09
Radio/TV Ad from Date:2021-08-10
Radio/TV Ad to Date:2021-08-10
Employer Received the Payment:N
Payment Details:
Bargaining Representative Notified:N/A
Posted Notice at Worksite:Y
Layoff in Past Six Months:N
US Worker Considered:
Country of Citizenship:CHINA
Foreign Worker Birth Country:CHINA
Class of Admission :H-1B
Employee Info
Foreign Worker Education:Master's
Foreign Worker Education Other:
Foreign Worker Major:BIOSTATISTICS AND EPIDEMIOLOGY
Year of Compelted Education:2017
Foreign Worker Istitution of Eduation:GEORGETOWN UNIVERSITY
Foreign Worker Education Instution Address Line 1:3700 O. STREET NW
Foreign Worker Education Institution Address Line 2:
