Director, Biostatistics – Oncology Data Strategy

Bicara Therapeutics; Boston; 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

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.