Vice President, Biometrics & Data Management

Bicara Therapeutics•Boston, MA

1d•Hybrid

About The Position

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.

Requirements

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.

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.