Director, Biostatistics Hematology

Position Summary

Director of Biostatistics is a member of a cross‑functional team and contributes to the development of compounds within a therapeutic area. The role drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. The Director develops trial designs that address study objectives supporting regulatory approval and market access, contributes to Clinical Development Plans, submissions, and post‑submission strategies, and provides guidance and management to statisticians to ensure high quality and timely deliverables.

Responsibilities include managing resources, setting priorities, and ensuring adherence to standards throughout the design, analysis, and report phases of clinical development.

• Drive innovative and efficient study design; develop designs that support regulatory approval, medical research, and market access.
• Lead, initiate, and oversee the statistical support for the development of compounds within a therapeutic area.
• Provide guidance and management to statisticians to ensure high quality and timely deliverables.
• Act as a scientific and strategic partner on high‑level development teams.
• Present and defend complex statistical solutions to governance, stakeholders, and external regulatory bodies.
• Contribute to Clinical Development Plans, lead GBDS related submission activities and post‑submission strategies.
• Provide statistical support and leadership for health authority requests, publications, presentations, and other public releases of information.
• Ensure compliance with BMS processes, SOPs, and global/project standards; maintain quality of deliverables.
• Create, maintain, and provide training on departmental SOPs and statistical topics.
• Manage a functional or project budget and allocate resources according to project needs.
• Represent BMS at professional societies and industry‑wide technical discussions.
• Contribute to the statistical community of practice and provide active coaching to team members.
• Communicate the GBDS Mission and Vision, fostering pride, excitement, and commitment within the team.
• Promote a culture of inclusiveness, respect for diversity, and constructive collaboration.

• Engage as an employee advocate and management coach/mentor for team members.
• Provide leadership to empower and develop the team.
• Guide employees’ development plans, conduct performance reviews and feedback, and develop performance metrics for staff.

• PhD (9+ years experience) or MS (11+ years experience) in statistics, biostatistics, or a related scientific field with clinical trials, drug development, pharmaceutical industry, or healthcare experience.
• Proficiency in scientific computing/programming (SAS, R, or Python) and implementation of advanced statistical analysis, data manipulation, graphing, and simulation.
• Excellent interpersonal, communication, writing, and organizational skills.
• Demonstrated expertise in applying general and cutting‑edge statistical/clinical trials methodology to solve complex problems and ensure alignment with regulatory agencies and industry standards.
• Experience in preparing and participating in global regulatory agency interactions.
• Proven collaboration, organizational, and leadership abilities with strong interpersonal skills.
• Experience developing approaches to enhance workforce planning and talent management strategies within a therapeutic area.
• At least 3 years of management (direct or matrix) experience preferred for people manager positions.

Berkeley Heights – NJ: $216,570 – $262,434
Princeton – NJ – US: $216,570 – $262,434

The starting compensation range listed above is for a full‑time employee (FTE)…