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Bicara Therapeutics, a clinical-stage biotech company founded in 2020, is seeking an experienced Director of Biostatistics to lead statistical activities for its oncology clinical programs. The company is pioneering bifunctional antibodies for targeted tumor modulation, with a focus on advancing its lead asset, ficerafusp alfa (FICERA), a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap.
In this role, you will serve as the lead statistician for assigned oncology programs and studies, providing both strategic direction and hands-on technical expertise. You will partner cross-functionally with Clinical, Regulatory, Medical, Statistical Programming, and Data Management teams to define and execute statistical strategies aligned with development objectives. Key responsibilities include providing statistical input to clinical protocols, Statistical Analysis Plans (SAPs), Case Report Forms (CRFs), and data management plans; overseeing execution of analyses and reporting deliverables; and performing or overseeing statistical analyses using SAS and/or R to ensure scientific rigor and reproducibility.
You will manage and oversee deliverables from Contract Research Organizations (CROs) and external vendors, providing statistical review, feedback, and quality control. The role involves contributing to the design and implementation of innovative statistical methodologies to enhance the efficiency and interpretability of oncology studies. You will promote statistical literacy across cross-functional teams, helping colleagues understand key concepts and data-driven insights, and support the development of publications, abstracts, and presentations through data interpretation and statistical input.
Required qualifications include a 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 (dose escalation, expansion cohorts, registrational studies); strong proficiency in SAS and/or R programming; working knowledge of CDISC standards (ADaM, SDTM); strong problem-solving, communication, and organizational skills; ability to work independently in a fast-paced environment; and experience managing CROs and collaborating in cross-functional matrix teams. Prior experience supporting regulatory submissions and interactions is preferred.
Bicara is headquartered in Boston with a global team of over 100 employees. The company is committed to building diverse teams and cultivating an inclusive culture.
