Director, Biostatistics

Bicara 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.

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.

Requirements

• 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 skill in SAS and/or R; working knowledge of CDISC standards (ADaM, SDTM).
• Strong problem-solving, communication, and organizational skills.
• Ability to work independently in a fast-paced environment.
• Experience managing CROs and collaborating in a cross-functional matrix team.
• Prior experience supporting regulatory submissions and interactions is preferred.

About the Company

Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA—a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms—ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients.

Pay

Compensation range: $236K - $274K