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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 two (2) Biostatisticians with our office in Pittsburgh, PA. The duties and responsibilities are as follows:
- Assume the responsibilities of Biostatistician and leadership for Biostatistics activities at the project level.
- Provide strategic, statistical, and scientific input to ensure analyses meet project goals, scientific and regulatory requirements.
- Manage multiple concurrent projects and participate in internal and client-facing meetings as needed.
- Perform statistical and programming tasks related to project deliverables, collaborating closely with cross-functional teams.
- Draft statistical sections of the protocols, statistical analysis plans (SAPs), statistical reports including clinical study reports (CSRs) and manuscripts; develop randomization schemes.
- Interpret and summarize study and statistical analysis results for internal and external stakeholders.
- Develop and/or review shell documents for tables, figures and listings (TFLs) and delivery of final outputs.
- Provide statistical review and programming support for ad hoc exploratory analyses requested by project team, programs and validate outputs as appropriate.
- Determine/define and apply appropriate statistical methodologies to support study objectives.
- Stay current with emerging statistical analysis methods and techniques in line with FDA guidance.
- Ensure consistency in the use of validated tools, training materials and compliance with standard processes, policies, and procedures.
- Perform additional duties as assigned to meet company needs and Sponsor milestones.
Minimum Requirements:
- Master’s Degree in Biostatistics, Business Analytics, or Applied Statistics.
- Must have completed at least 4 semester-long graduate-level courses in applied statistics, probability, data science, machine learning, and mathematical statistics. Minimum 2 courses in writing and speaking.
Please send all applications to serena.sin@stat4ward.com
Wage: $75,756 to $84,876