Senior Director of Biostatistics (Oncology Programs)

Quick Facts

• Role: Senior Director of Biostatistics (Oncology Programs)

• Scope: Strategic biostatistics leadership for late-stage oncology development

• Reporting: Head of Oncology Biostatistics

Description

The Senior Director of Biostatistics leads and develops a team of statisticians supporting late-stage (Phase 3) oncology development. You will provide statistical leadership across development planning, regulatory interactions, and HTA/commercial evaluations for one or more oncology assets/indications. The role also requires strong cross-functional collaboration and people leadership.

Responsibilities

• Provide strategic statistical leadership for Phase 3 oncology trials, including design optimization and quantitative decision support

• Act as Biostatistics statistical lead for assigned molecules/indications; represent the function in Health Authority interactions

• Partner with Statistical Programming, Clinical Research, Data Management, Clinical Operations, Global Drug Safety, Regulatory, and Project Management to deliver timely, high-quality analyses and clinical reports

• Apply statistical and regulatory principles to meet scientific, regulatory, and business objectives; support regulatory strategy, risk assessment, publications, and presentations

• Lead, mentor, and develop high-performing statistician teams; manage staffing strategy, succession planning, and workforce planning

• Use external scientific/regulatory intelligence (academia/industry/Health Authorities) to inform development strategy and scientific credibility

• Drive judgment, decision-making, communication, and alignment across functions in fast-paced environments

• Build partnerships across Biostatistics and stakeholders to foster collaboration and a culture of excellence

Requirements

• Bachelor’s plus 14 years experience OR Master’s plus 12 years experience OR PhD plus 12 years experience

• Strong track record in statistical methods for drug development, especially late-stage (Phase 3) oncology

• Experience with NDA and/or BLA submission leadership (preferred)

• Extensive experience with global Health Authority interactions and regulatory strategy/labeling (preferred)

• Deep biostatistics expertise using industry-standard statistical software

• Proven people-management experience leading and developing teams of statisticians

Benefits

• Salary range: $261,375.00 - $338,250.00 (base compensation varies by experience, qualifications, and geographic location)

• Discretionary annual bonus (if eligible)

• Discretionary stock-based long-term incentives (eligibility may vary)

• Paid time off

• Company-sponsored medical, dental, vision, and life insurance plans