Associate Director, Biostatistics - Hematology

Role Summary

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development. The incumbent will lead Biostatistics efforts with cross-functional teams to articulate drug development questions, design clinical experiments, generate and analyze data, and interpret results. The role involves regulatory interactions, training of non-statistical colleagues, development of infrastructure, and mentoring junior statisticians.

Responsibilities

• Represent Biostatistics at Global Clinical sub-teams.
• Interact 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 interactions, including drafting analysis plans and reviewing TFLs for regulatory meetings and slides for advisory committees.
• Lead and contribute to process improvement and technical working groups; establish timelines and deliverable expectations; author new or revised SOPs and contribute to cross-functional EPIC workstreams.
• Evaluate software for planned analyses and determine needs for novel statistical methodologies 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 provide training to non-statisticians.

Qualifications

• PhD or equivalent degree in statistics/biostatistics with >6 years of experience in the pharmaceutical industry OR MS degree in statistics/biostatistics with >11 years of experience
• Preferred: Hematology, IO, non-oncology, Multiple Myeloma experience or similar Therapeutic Area.
• Time to Event (TTE) experience.
• Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.
• Excellent influence and leadership skills, and a demonstrated 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 effective communication skills.
• Solid knowledge of statistical analysis methodologies and experimental and clinical trial design.
• Expertise in statistical software.

Skills

• Cross-functional collaboration
• Regulatory interactions and communication
• Clinical trial design and data analysis
• Technical leadership and mentoring
• Training and knowledge transfer to non-statisticians

Education

• PhD or MS in statistics/biostatistics (as specified in Qualifications)