The Principal Biostatistician will have experience in all required areas as a Senior Biostatistician. The Principal Biostatistician is a subject matter expert in Biostatistics. They will apply a high degree of statistical expertise to advance and influence clinical programs from a statistical perspective. The Principal Biostatistician will mentor and develop members of the Biostatistics team.

Responsibilities:

• Exceed expectations and responsibilities of a Senior Biostatistician
• Serve as statistical lead on complex clinical trials; or serve as portfolio lead across a large suite of studies for a sponsor
• Serve as statistical lead for Integrated Summaries of Safety and Integrated Summaries of Efficacy
• Provide statistically sound input on clinical trials; demonstrating solid understanding of all key design components (defining study objectives, study design and plan, study populations, treatment regimens as well as determining sample size requirements)
• Utilize statistical software to implement advanced statistical methodologies
• Train and mentor others in task execution
• Represent sponsor at FDA meetings; respond to requests from regulatory agencies
• Advise and consult with sponsors regarding regulatory filing requirements
• Develop department training materials and deliver trainings to the team
• Drive/facilitate/actively engage in department initiatives
• Standard Operating Procedures (SOPs)

• Strong understanding of departmental and company procedures; ability to guide others on procedures
• Participate in the development and revision of department SOPs
• Business Development

• Support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.
• Additional Responsibilities

• Assist in the preparation and review of monthly financial reporting
• Promote visibility outside of the functional area and effectively interact cross-functionally and in industry
• Perform other duties as requested by management

Qualifications:

• The ideal candidate should have an advanced degree (MS or PhD) in Statistics or a closely related field
• Minimum of 8 years direct Biostatistics experience in pharmaceutical development or CRO environment
• Excellent oral and written communication skills, organizational skills, and attention to detail are required

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.