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 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.