Associate Director, Biostatistics

Position Overview

Bicara is seeking an experienced Associate Director, Biostatistics, to lead statistical activities supporting our clinical oncology programs. This individual will provide both strategic direction and hands-on expertise, shaping study design, data analysis, and evidence generation. In this highly visible role within a growing biotech organization, the Associate 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.
• Contributes 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.
• Minimum 8 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.

Company Overview

Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.