JOB POSTING NOTICE
THIS NOTICE IS BEING PROVIDED AS A RESULT OF, AND IN CONNECTION WITH, THE FILING OF A PERMANENT ALIEN LABOR CERTIFICATION APPLICATION FOR THE JOB OPPORTUNITY IDENTIFIED BELOW. ANY PERSON MAY PROVIDE DOCUMENTARY EVIDENCE BEARING ON THE APPLICATION TO THE CERTIFYING OFFICER OF THE DEPARTMENT OF LABOR.
U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
Atlanta National Processing Center
200 Constitution Ave NW
Room N-5311
Washington, DC 20210
JOB DESCRIPTION:
Biostatistician
Stat4ward LLC provides statistical consulting services to pharmaceutical, medical device, and diagnostic companies, as well as other fields that use general statistics. Our highly-trained statisticians are experts in the pharmaceutical and IVD/LDT industries, who focus on data analysis, study design, and statistical analysis planning. We also support and guide critical decision-making, publications, submissions, and interactions with regulatory agencies. To learn more about us, please feel free to visit our website: https://stat4ward.com/
We are currently looking for a Biostatistician with our office in Pittsburgh, PA. The duties and responsibilities are as follows:
- Leads statistical activities at the project level and manages multiple projects.
- Ensures sound strategic, statistical, and scientific input to projects and data analyses to meet project needs and regulatory and scientific requirements.
- Performs project-related statistical and programming activities including contributing to cross-functional teams.
- Determine/define statistical methodologies.
- Drafts statistical sections of the protocol, statistical analysis plan (SAP), and statistical reports including clinical study reports (CSR) and manuscripts, and generates randomization scheme.
- Interprets study and statistical analysis results.
- Develops and/or reviews Tables, Figures, and Listings shell document for delivery.
- Provides statistical review of ad hoc exploratory analyses requested by project team, programs and validates outputs as appropriate.
- Maintain knowledge on the latest statistical analysis methods and techniques in line with FDA guidance.
- Ensures consistent use of training materials and compliance with standard processes, policies, and procedures.
- Additional tasks not described within to meet company requirements and Sponsor milestones.
MINIMUM REQUIREMENTS:
- Master’s Degree in Biostatistics, Business Analytics, or Applied Statistics.
- Minimum 3 courses in college statistics
- Minimum 2 courses in writing and speaking
CONTACT: Please direct all applications via email to: serena.sin@stat4ward.com
WAGE: $73,080 per year Posted on 4/28/2025