Type: Contract – may convert into a full time salaried role at the end of the contract
Location: Lawrenceville, NJ – Hybrid, must be commutable and work onsite 2 days per week
Biostatistician opportunity available for a global pharmaceutical company in NJ.
Job Details
Serving as Study Statistician responsible for the development of statistical strategies, operational executions, and statistical aspects of assigned projects and studies.
Contributing to clinical trial design, the statistical sections of study protocols, and developing and authoring Statistical Analysis Plans (SAPs).
Overseeing CRO activities, providing clear and explicit guidance in the development and finalization of TLF shells and TLF final productions.
Managing timelines, reviewing and verifying all deliverables, and validating primary and key analyses of the clinical study reports (CSRs) to ensure that the statistical deliverables are of high quality and compliant with client's SOPs and standards.
Responsible for the statistical interpretation of data and analysis results, ensuring proper incorporation in the clinical study reports
Principal Duties And Responsibilities
Contribute to study design, develop statistical sections of study protocol, develop statistical analysis plan and analysis results, provide statistical consultation to clinical study team
Review and contribute to the development of study related documents/activities: protocol, CRF, database setup, data cleaning plan, clinical study report, etc.
Participate in statistical vendor selection, manage and monitor vendor activities and deliverables, review and QC the statistical output, manage and maintain the final statistical output transferred from venders
Participate in study management with project leader and study team members to ensure adherence to timelines
Contribute to the development and maintenance of standardization, process improvement, and standard operating procedures
Maintain up-to date knowledge in the application of statistical methods and the regulatory requirements in drug development
Develop and maintain in-depth knowledge regarding disease and drug mechanism of the medical specialty areas that are assigned
Minimum Requirements:
5 years of experience in Biostatistics in the pharmaceutical industry with a Master Degree.
3 years of experience in the pharmaceutical industry with a PhD Degree.
Proficiency in SAS programming
Seniority level
Associate
Employment type
Contract
Job function
Research, Analyst, and Information Technology
Industries
Business Consulting and Services
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