Senior Biostatistician

About the Role:

Premier Research is seeking a highly skilled Senior Biostatistician to join our Statistics team. As a key member of our team, you will play a crucial role in helping biotech, medtech, and specialty pharma companies transform life-changing ideas into new medicines, devices, and diagnostics.

Key Responsibilities:

• Provide statistical consulting to support the design and analysis of clinical trials
• Develop and implement statistical analysis plans (SAPs) in accordance with protocols and regulatory requirements
• Prepare statistical sections of protocols, including sample size and power calculations, and create randomization schedules
• Review and provide input on analysis data specifications, data management plans, and other related study documents
• Support the development of integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
• Develop SAS programs to create derived variables and analysis data sets, and generate listings, tables, and graphs using SAS
• Perform quality control of analysis data and review and provide input on analysis results

Requirements:

• Advanced degree (MS or PhD, or equivalent) in statistics or a closely related field, along with 4-6 years (or 3-5 years for PhD) of direct experience in clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
• Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with others on the project team and in the department
• Detail-oriented, well-organized, and able to work on several projects simultaneously
• Excellent team player, collaborative, and maintains a positive, results-oriented work environment
• Accountable, dependable, and demonstrates strong commitment to the role
• Customer service-focused in approach to work, both internally and externally

About Premier Research:

Premier Research is a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. Our values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility, and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.

Why Choose Premier Research?

• We provide innovative technologies and continuous learning opportunities to support our staff in delivering medical innovation that patients are desperate for
• We are committed to diversity, equity, inclusion, and empowerment, creating a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve
• We hire people that add to our culture, then invest in developing skills and abilities