Director, Biostatistics
Bicara Therapeutics
August 25, 2026
Remote friendly (Boston, MA)
United States
$236,000 - $274,000 USD yearly
Clinical Research and Development
Responsibilities:
- Serve as lead statistician for assigned oncology programs and studies.
- Partner cross-functionally with Clinical, Regulatory, Medical, Statistical Programming, and Data Management 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 efficiency and interpretability of oncology studies.
- Promote statistical literacy across cross-functional teams.
- Support development of publications, abstracts, and presentations via 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.
- Hands-on experience designing and analyzing oncology trials (e.g., dose escalation, expansion cohorts, registrational studies).
- Proficient programming 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/interactions (preferred).
- Serve as lead statistician for assigned oncology programs and studies.
- Partner cross-functionally with Clinical, Regulatory, Medical, Statistical Programming, and Data Management 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 efficiency and interpretability of oncology studies.
- Promote statistical literacy across cross-functional teams.
- Support development of publications, abstracts, and presentations via 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.
- Hands-on experience designing and analyzing oncology trials (e.g., dose escalation, expansion cohorts, registrational studies).
- Proficient programming 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/interactions (preferred).