Director of Oncology Biostatistics & Strategy

Bristol Myers Squibb; Cambridge (MA); Hybrid; USD 279,000 - 339,000; Full time

Job summary

Bristol Myers Squibb in Cambridge, MA is seeking a Senior Director of Oncology Biostatistics to lead the Biostatistics function within therapeutic areas, shaping study design and analyses for global product development and market access efforts. You will guide statisticians, ensure high-quality deliverables, and align with regulatory standards.

The role requires extensive statistics expertise, regulatory collaboration experience, and strong leadership to manage resources and mentor teams within

Qualifications

• PhD or MS (12+ years’ experience) in statistics or biostatistics or 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 & simulation
• Excellent interpersonal, communication, writing and organizational skills
• Demonstrate expertise in applying knowledge of general and cutting edge statistical / clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards
• Extensive experience in preparing and participating in global regulatory agency interactions
• Demonstrate excellent collaboration, organizational/ leadership abilities, and interpersonal skills
• Demonstrate development of resourcing strategies and recruiting practices, working with senior leaders to define positions and organizational structure, and anticipating future requirements and specialty areas
• At least 5 years management (direct or matrix) experience is preferred (for people manager position only)

Responsibilities

• Manages a functional or project budget, and has authority to allocate company resources according to the development needs of multiple compounds/indications within therapeutic areas, and sets priorities
• Directs and guides statisticians to ensure high quality and timely deliverables
• Compliant with BMS processes and SOPs, adherence to global and project standards
• Ensures consistency and adherence to standards across therapeutic areas and projects
• Key contributor to Clinical Development Plans, submissions, and post-submission strategies/preparation/ defense as needed
• Represents the company in interfaces with regulatory agencies globally
• Drives strategy for processes improvement, contributes to new departmental SOPs, and provides training on statistical topics and departmental SOPs
• Participates in industry-wide technical discussions, and represents company in professional societies
• Encourages new ideas, innovation, and continuous improvements across DQS
• Anticipates potential issues and takes preventive measures; identifies and oversees the resolution for the team
• Effectively engages as a matrix team member on high level development teams and acts as a scientific and strategic partner
• Seeks and establishes new collaborations with cross-functional areas; maintains existing stakeholder collaborations
• Contributes to functional goal setting and forward planning
• Effectively communicates the DQS Mission and Vision in a fashion that generates pride, excitement and commitment within DQS
• Enables a culture of inclusiveness, respect for process which allows for the questioning and challenging of others in a respectful and constructive manner

Skills

Communication

Leadership

Statistical analysis

Regulatory experience

Collaboration

Education

PhD or MS in statistics/biostatistics

Tools

SAS

R

Python

Job description

Bristol Myers Squibb in Cambridge, MA is seeking a Senior Director of Oncology Biostatistics to lead the Biostatistics function within therapeutic areas, shaping study design and analyses for global product development and market access efforts. You will guide statisticians, ensure high-quality deliverables, and align with regulatory standards.

The role requires extensive statistics expertise, regulatory collaboration experience, and strong leadership to manage resources and mentor teams within