Principal Biostatistician

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