Job Posting for Principal Biostatistician at Advanced Clinical
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.
Salary.com Estimation for Principal Biostatistician in Deerfield, IL
$122,125 to $159,888
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