Remote AD Biostatistics Late Stage Oncology

Associate Director, Biostatistics Late-Stage Oncology

Remote (must be EST or Central Time Zone) or Massachusetts location

Salary: $190-210,000 base salary 20% bonus LTI additional benefits

We're partnered with a commercial-stage biopharmaceutical organization is seeking an experienced Associate Director, Biostatistics to join its Global Biometrics team. This individual will provide statistical leadership across oncology development programs, partnering closely with Clinical Development, Regulatory Affairs, Medical Affairs, and cross-functional stakeholders to drive high-quality decision-making throughout the product lifecycle.

This is an excellent opportunity for a biostatistics leader seeking increased visibility and strategic influence while supporting innovative oncology programs through late-stage development, regulatory submissions, and evidence-generation activities.

Position Summary

As an Associate Director, Biostatistics, you will be responsible for leading statistical strategy and execution across one or more oncology assets and indications. You will contribute to clinical development plans, study designs, regulatory submissions, and evidence-generation activities while serving as a key strategic partner to clinical and regulatory teams.

This role offers significant exposure to senior leadership and provides the opportunity to influence development strategy, regulatory interactions, and key business decisions.

Key Responsibilities

Statistical Leadership

• Provide strategic statistical leadership across late-stage oncology development programs and clinical studies.
• Direct statistical analyses, review outputs, and ensure accurate interpretation of clinical trial results.
• Select and implement appropriate statistical methodologies for study design and data analysis.
• Partner with physicians, clinical scientists, and cross-functional stakeholders to support data-driven decision-making.

Development & Regulatory Strategy

• Contribute to overall product development strategy through innovative statistical approaches and decision-support tools.
• Support interactions with regulatory authorities and external scientific organizations on statistical matters.
• Lead statistical contributions to CSRs, integrated summaries, submission dossiers, and key regulatory documents.
• Ensure statistical perspectives are incorporated into regulatory discussions, submissions, and external engagements.

Cross-Functional Partnership

• Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, and Evidence Generation teams.
• Provide scientific guidance on conclusions and interpretation of clinical data packages.
• Support publication strategies through review of abstracts, posters, and manuscripts.

Operational Excellence

• Plan and manage statistical deliverables, timelines, and resource allocation across projects.
• Contribute to process improvement initiatives and the development of departmental standards and quality documents.
• Monitor evolving regulatory guidance and industry standards to ensure continued compliance and excellence.

Required Qualifications

Education

• PhD in Biostatistics, Statistics, or a related quantitative discipline with a minimum of 5 years of pharmaceutical industry experience.
• Master's degree may be considered with significant additional relevant experience.

Experience & Technical Expertise

• Strong experience supporting oncology clinical development programs, ideally including late-stage and registration-enabling studies.
• Deep understanding of statistical methodologies applied across clinical development.
• Demonstrated expertise in clinical trial design, statistical analysis plans, and regulatory submissions.
• Working knowledge of FDA, EMA, ICH, and other applicable regulatory guidance.
• Experience supporting regulatory filings and responding to health authority questions preferred.
• Proficiency in SAS strongly preferred.

Leadership Competencies

• Strong communication and stakeholder management skills.
• Ability to influence cross-functional teams and drive strategic decision-making.
• Demonstrated sound judgment, adaptability, and business acumen.
• Proven ability to manage multiple priorities in a fast-paced development environment.

Location & Travel

• Boston-based hybrid model preferred (2-3 days onsite weekly).
• Fully remote candidates located within the United States (EST and Central Timezone) will also be considered.
• Occasional domestic and international travel required.

Why This Opportunity?

• High-impact role supporting innovative oncology programs.
• Significant visibility across cross-functional leadership teams.
• Opportunity to influence development strategy and regulatory success.
• Collaborative, science-driven environment focused on advancing meaningful therapies for patients.
• Strong compensation package including base salary, annual bonus, long-term incentives, and comprehensive benefits.

Ideal Profile: A scientifically rigorous oncology biostatistician who enjoys partnering closely with clinical leaders, influencing development strategy, and contributing to the advancement of late-stage oncology assets through registration and commercialization.