AD Biostatistics Oncology
Associate Director, Biostatistics - Late Stage Oncology
Role Overview
Remote/Greater Boston Area
The Associate Director, Biostatistics will serve as a key member of the Global Biometrics organization, providing strategic and hands‑on statistical leadership across one or more oncology assets or indications. This role is responsible for delivering high‑quality statistical input across clinical development programs, including study design, execution, analysis, interpretation, and regulatory submissions.
As a strategic partner to Clinical Development, Regulatory, Medical Affairs, and other evidence‑generation stakeholders, the Associate Director ensures scientific rigor, regulatory relevance, and data‑driven decision‑making throughout the product lifecycle.
Key Responsibilities
Clinical Development & Statistical Leadership
- Lead statistical support for one or more oncology assets or indications, overseeing study‑level and program‑level statistical strategy across phases of development.
- Direct the execution and review of statistical analyses, ensuring accuracy, interpretability, and clear communication of clinical results to cross‑functional stakeholders.
- Serve as a strategic statistical partner to physicians, clinical scientists, regulatory leads, and evidence generation teams on data interpretation and decision‑making.
Study Design, Analysis & Reporting
- Select and apply appropriate statistical methodologies for clinical trial design and data analysis, including innovative and fit‑for‑purpose approaches.
- Review and contribute to clinical protocols, Statistical Analysis Plans (SAPs), and statistical sections of study reports, including CSRs and integrated summaries.
- Oversee development, review, and quality of Tables, Figures, and Listings (TFLs), mock shells, and data packages supporting key milestones and submissions.
Regulatory & External Engagement
- Represent Biostatistics in interactions with regulatory authorities and external bodies, contributing statistical input to regulatory strategy and responses.
- Ensure statistical perspectives are effectively integrated into regulatory meetings, submissions, and external communications.
- Monitor evolving regulatory guidance, HTA expectations, and industry standards, updating internal practices as needed to maintain compliance.
Program & Resource Management
- Plan, track, and prioritize biostatistics deliverables across multiple projects, optimizing timelines and resource utilization.
- Partner with internal biostatistics colleagues and external CROs or consultants to ensure high‑quality, on‑time statistical deliverables.
- Ensure best practices are followed in all dealings with CRO and vendor partners.
Scientific Contribution & Process Improvement
- Contribute to publication strategies by reviewing abstracts, posters, and manuscripts in collaboration with Medical Affairs and cross‑functional teams.
- Support departmental process improvement initiatives, including development and maintenance of standardized statistical templates and quality documents.
- Contribute to the establishment and ongoing use of common formats for protocols, SAPs, CRF statistical components, and reporting deliverables.
Education & Experience
- Ph.D. in Biostatistics, Statistics, or a closely related field with at least 5 years of relevant pharmaceutical or biotechnology experience; OR
- Master's degree in Statistics or related discipline with at least 8 years of relevant industry experience.
- Direct regulatory submission experience (e.g., IND, NDA, BLA) strongly preferred.
Required Competencies & Skills
- Deep knowledge of advanced statistical concepts and their application across all phases of clinical development.
- Demonstrated ability to design and analyze clinical trials and other evidence‑generation studies.
- Strong working knowledge of SAP development, CSR structure, TFL shells, and appendices.
- Proficiency in SAS strongly preferred.
- Comprehensive understanding of applicable regulatory guidance and industry standards (e.g., ICH, FDA, EMA).
- Proven experience responding to regulatory questions and supporting external reviews.
- Strong judgment, decision‑making ability, and adaptability in a dynamic development environment.
- Excellent communication skills, with the ability to convey complex statistical concepts to non‑statistical audiences.
Salary: 190-220,000 base salary + 20% bonus + LTI + additional benefits
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