Director, Biostatistics – Oncology Data Strategy

Bicara Therapeutics, Inc.; Boston (MA); Hybrid; PHP 11,097,000 - 17,263,000; Full time

Job summary

Bicara Therapeutics is seeking an experienced Director of Biostatistics to lead statistical activities supporting oncology clinical programs. This Boston-based role offers a hybrid schedule with three in-office days per week and opportunities to shape study design, data analysis, and evidence generation.

The candidate will guide cross-functional teams, oversee CRO partners, and contribute to regulatory submissions, publications, and strategic planning in a fast-paced biotech environment.

Qualifications

• 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.
• Hands-on experience designing and analyzing oncology trials (e.g., dose escalation, expansion cohorts, registrational studies).
• Strong programming skills 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.

Responsibilities

• 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.
• Provide statistical input to clinical protocols, SAPs, CRFs, and data management plans; oversee analyses and reporting deliverables.
• Perform or oversee statistical analyses using SAS and/or R, ensuring rigor and reproducibility.
• Manage and oversee deliverables from CROs and external vendors, providing statistical review and quality control.
• Contribute to the design and implementation of innovative statistical methodologies to enhance study efficiency and interpretability.
• Promote statistical literacy across cross-functional teams, helping colleagues understand data-driven insights.
• Support the development of publications, abstracts, and presentations through data interpretation and statistical input.

Skills

SAS programming

R programming

Oncology trial design

CDISC standards (ADaM/SDTM)

Leadership

Vendor management

Education

Master’s or PhD in Biostatistics/Statistics

Tools

SAS

R

Job description

Position Overview

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

• Contribute 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.

• 10+ 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 skills 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 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.