Role Summary

A large, established pharmaceutical company with a broad and active clinical pipeline is seeking an Associate Director of Biostatistics to join its biometrics organization on a hybrid basis in Boston. Reporting to the Therapeutic Area Head of Biostatistics, this is a project-level statistical role for an experienced biostatistician who is ready to take ownership of studies across the development portfolio. The successful candidate will be a strong individual contributor with the confidence to lead statistical activities end-to-end, engage cross-functionally, and represent biostatistics in both internal and external settings.

Responsibilities:

• Serve as the lead study statistician across assigned clinical trials, with accountability for statistical strategy, design, and delivery from study initiation through to reporting.
• Author and review statistical documents including protocol sections, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs).
• Lead sample size calculations, endpoint selection, and analysis planning, applying appropriate and innovative statistical methodologies.
• Collaborate cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, and Data Management to guide study execution and data interpretation.
• Oversee CRO and vendor statistical deliverables, ensuring outputs meet quality, timeline, and compliance expectations.
• Support regulatory submission activities, including contributing to IND, NDA, and BLA packages, and responding to health authority queries.
• Review CDISC data packages and provide statistical input into data review activities.
• Represent biostatistics in cross-functional working groups, governance forums, and external meetings with regulatory authorities.
• Contribute to departmental initiatives including SOP development, process improvement, and the establishment of statistical best practices.

Requirements:

• Advanced degree (PhD or Master's with supplementary experience) in Biostatistics or a closely related field.
• Significant industry experience in biostatistics within a pharma, biotech, or CRO environment, with a demonstrated ability to lead studies independently.
• Strong experience across multiple phases of clinical development, including late-phase trials.
• Proven track record supporting regulatory submissions, with experience contributing to IND, NDA, or BLA packages.
• Comfortable engaging with health authorities and representing biostatistics in regulatory interactions.
• Well versed in working with external CRO and vendor partners and managing the quality of inbound deliverables.
• Strong communication skills, both written and oral, with the ability to convey complex statistical concepts clearly to non-statistical audiences.
• Highly organized, collaborative, and effective in a matrixed, large-organization environment.

Compensation DOE - $190,000 - $240,000 base salary + benefits