Remote AD Biostatistics Late Stage Oncology

We're partnered with a commercial-stage biopharmaceutical organization 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.

About the Role

As an Associate Director, Biostatistics, you will lead 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.

Requirements

• 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.
• 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.

Skills

• 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.

Schedule

• 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.

Pay

$190-210,000 base salary + 20% bonus + long-term incentives.

Benefits

• Comprehensive benefits package.