Associate Director, Biostatistics - Hematology

Role Summary

Associate Director, Biostatistics - Hematology. This position supports Clinical Biostatistics within Global Development, leading biostatistics efforts, mentoring staff, and contributing to regulatory interactions and methodological innovation.

Responsibilities

• Lead the Biostatistics department's contributions with cross-functional teams to articulate drug development questions, assess endpoint feasibility, frame statistical approaches, design clinical experiments, analyze data, and interpret results for decision making.
• Represent statistical issues in regulatory agency meetings and contribute to regulatory submissions and communications.
• Develop and deliver training to non-statistical colleagues and lead the development of new infrastructure and processes; represent the company in professional associations, conferences, and publications.
• Mentor and oversee less experienced statisticians, with potential to manage full-time staff.
• Represent Biostatistics at Global Clinical sub-teams; collaborate with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
• Lead contributions to regulatory-interaction materials, including drafting analysis plans and reviewing tables, figures, and slides for regulatory meetings and advisory committees.
• Lead process improvements and technical working groups, set timelines and deliverable expectations; author/update SOPs and contribute to cross-functional EPIC workstreams.
• Evaluate software applicability for planned analyses and identify needs for novel statistical methods or tools.
• Prepare presentations and written reports to communicate results to project teams, management, and regulatory agencies; co-present findings to management.
• Engage in research activities for innovative statistical methods and applications in clinical trial development and provide training to non-statisticians.

Qualifications

• PhD or equivalent in statistics/biostatistics with >6 years of pharmaceutical industry experience, or MS in statistics/biostatistics with >11 years of experience
• Knowledge of drug discovery and development and ability to integrate statistical concepts into development strategies
• Excellent influence and leadership skills with ability to collaborate in a cross-functional environment
• Ability to work productively in a fast-paced, collaborative environment with strong critical thinking, time management, and communication skills
• Solid knowledge of statistical analysis methodologies and experimental/clinical trial design
• Expertise in statistical software

Skills

• Statistical methodologies
• Clinical trial design
• Cross-functional collaboration
• Regulatory communication
• Data interpretation and presentation

Education

• PhD in statistics/biostatistics or MS with extensive pharmaceutical industry experience as specified above