Vice President, Biometrics & Data Management

Position Overview

Bicara Therapeutics is seeking an experienced and strategic Vice President, Biometrics and Data Management. Reporting to the EVP, Clinical Development, this head of Biometrics and Data Management will provide executive leadership and strategic direction for Biostatistics, Statistical Programming, and Data Management across the Oncology portfolio. This role will be accountable for building and guiding a multi-disciplinary team, providing strategic and operational leadership for all statistical and data functions within the Oncology pipeline.

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

Responsibilities

• Define and execute the biostatistics and data management strategy, setting clear goals that align with the oncology clinical development objectives.

• Provide statistical leadership in the design and execution of clinical trials across the various stages of development, and registrational strategies.

• Build a high performing team and build processes, SOPs, and governance frameworks to ensure efficiency, standardization, and compliance across the portfolio.

• Drive innovation in statistical methods, automation, and analytics to improve decision-making and execution speed.

• Participate in the design and review of clinical protocols including the preparation of statistical considerations sections, sample size calculations, interim looks, randomizations, and study design recommendations.

• Ensure programming workflows and data management processes support regulatory readiness (application of CDISC, regulatory and internal standards).

• Establish governance for data standards, data quality, validation, and submission readiness.

• Serve as a core representative in cross-functional meetings, aligning biostatistics, programming, and data strategy with clinical development, regulatory affairs, and quality assurance.

• Lead interactions with health authorities (e.g., FDA, EMA, PMDA) to address statistical and data questions during regulatory reviews.

• Oversee CRO and vendor strategy, including selection, performance management, and cost optimization.

Qualifications

• Advanced degree (PhD preferred) in Biostatistics, Statistics, Computer Science, Data Science or related quantitative field.

• 15+ years experience in clinical biostatistics, statistical programming, and data management, ideally within oncology or related therapeutic areas.

• Demonstrated leadership and people management experience with multi-disciplinary teams.

• Proficiency with statistical software (SAS, R) and clinical data standards (CDISC SDTM/ADaM).

• Strong understanding of regulatory requirements and clinical development processes.

Company Overview

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. For more information, please visit www.bicara.com.

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.