Principal Biostatistician

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• We are Built by You. Your ideas influence the way we work, and your voice matters here.

• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for Biotech™. Join us and build your future here.

What You'll Be Doing:

• Lead Biostatistical Activities: You'll serve as the Lead Biostatistician on assigned projects, interacting directly with study teams and sponsors, providing expert statistical input for clinical trial protocols and reports, and offering consultancy on complex statistical issues.
• Generate and Validate Clinical Trial Deliverables: You will be responsible for generating derived datasets, tables, listings, and figures (TLFs) from clinical trial data, as well as performing meticulous quality control (QC) of deliverables created by other biostatisticians. You will also supervise SAS programming and program validation for projects.
• Develop and Review Statistical Documentation: You'll independently draft and peer-review statistical analysis plans, ensuring accuracy and adherence to standards, and prepare detailed specifications for CDISC and other analysis data sets.
• Manage Project Timelines and Financials: You'll play a key role in managing the timelines and budgets of your assigned tasks, including tracking project revenue, backlog, and hours worked, and forecasting necessary hours to ensure project completion.
• Support Business Development Initiatives: You'll assist with biostatistics cost estimations for proposals, prepare for and attend bid defense and capabilities meetings, and present biostatistical capabilities to potential sponsors.
• Contribute to Team Development and Standards: You will participate in the training and development of new biostatisticians, contribute to the maintenance of biostatistical sections within the Trial Master File (TMF), and ensure compliance with confidentiality and security regulations.

What We Are Searching For:

• Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field. Equivalent combination of education, training and experience will be considered. 
• ​12-15 years’ experience in clinical trials design and analysis 
• ​Demonstrated expert working knowledge of basic clinical trial design and analysis principles. 
• ​Expert working knowledge of advanced statistical concepts and CDISC standards and application of these standards to projects. 
• ​Strong computer skills, with evidence of advanced programming skills especially statistical inferential procedures 
• ​Demonstrated experience in interacting with regulatory agencies (e.g. FDA, EMA, EU member states) 

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $170,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

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Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status