Biostatistics Director

Position Overview

Bicara Therapeutics is seeking an experienced Director of Biostatistics to lead statistical activities supporting our oncology clinical programs. This individual will provide both strategic direction and hands-on expertise, shaping study design, data analysis, and evidence generation across the development. In this highly visible role within a growing biotech organization, the Director will collaborate closely with internal teams and external partners to deliver high-quality, data-driven insights that advance our oncology pipeline. The ideal candidate thrives in a dynamic, fast-paced environment and is eager to contribute both technically and strategically to program success.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities

• Serve as the lead statistician for assigned oncology programs and studies.

• Partner cross-functionally with Clinical, Regulatory, Medical, Statistical Programming, and Data Management teams to define and execute statistical strategies aligned with development objectives.

• Provide statistical input to clinical protocols, SAPs, CRFs, and data management plans; oversee execution of analyses and reporting deliverables.

• Perform or oversee statistical analyses using SAS and/or R, ensuring scientific rigor and reproducibility.

• Manage and oversee deliverables from CROs and external vendors, providing statistical review, feedback, and quality control.

• Contribute to the design and implementation of innovative statistical methodologies to enhance the efficiency and interpretability of oncology studies.

• Promote statistical literacy across cross-functional teams, helping colleagues understand key concepts and data-driven insights.

• Support the development of publications, abstracts, and presentations through data interpretation and statistical input.

Qualifications

• Master’s degree or PhD in Biostatistics, Statistics, or a related quantitative field.

• 10+ years of industry experience, including 5+ years in oncology clinical development.

• Demonstrated hands-on experience in designing and analyzing oncology trials (e.g., dose escalation, expansion cohorts, or registrational studies).

• Strong and proficient programming skills in SAS and/or R; working knowledge of CDISC standards (ADaM, SDTM).