Title: Senior Biostatistician

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

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.