Principal Biostatistician

Position Purpose:

You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician will implement statistical strategies for clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables

Main Responsibilities:

• Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions
• Lead components and fully support Biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation
• Author the initial statistical analysis plan for clinical trials and regulatory submissions. Be accountable for timely completion and quality of the statistical analysis plan.
• Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA)
• Be responsible for interpreting analysis results and ensuring reporting accuracy
• Manage outsourcing operations or work with internal statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct reviews of deliverables to ensure quality.
• Be accountable for the TFL/CDISC package for study report and regulatory submission
• Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations

Minimum Qualifications and Experience Requirements:

• PhD or MS in Biostatistics, Statistics
• 7+ years or relevant work experience in the pharmaceutical industry and/or CRO
• Experience either managing a CRO, or having worked in a CRO
• Experience providing statistical leadership at a study level
• Demonstrated statistical contribution in facilitating and optimizing clinical development