Associate Director, Biostatistics jobs in United States
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Bicara Therapeutics · 2 days ago

Associate Director, Biostatistics

Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. They are seeking an experienced Associate Director, Biostatistics, to lead statistical activities for their clinical oncology programs, providing strategic direction and hands-on expertise in study design and data analysis.

BiopharmaBiotechnologyLife ScienceOncologyTherapeutics

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
Contributes 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

Qualification

BiostatisticsOncology clinical developmentSASRCDISC standardsCRO managementRegulatory submissionsProblem-solvingCommunicationOrganizational skillsIndependent workCross-functional collaboration

Required

Master's degree or PhD in Biostatistics, Statistics, or a related quantitative field
Minimum 8 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 skill 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

Preferred

Prior experience supporting regulatory submissions and interactions

Company

Bicara Therapeutics

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Bicara Therapeutics develops dual-action cancer therapies, combining targeted treatments with tumor modulators for enhanced impact. It is a sub-organization of Biocon.

Funding

Current Stage
Public Company
Total Funding
$313M
Key Investors
Biocon
2024-09-13IPO
2023-12-12Series C· $165M
2023-03-06Series B· $108M

Leadership Team

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Claire Mazumdar
Chief Executive Officer
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David Raben
CMO, Bicara Therapeutics
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Company data provided by crunchbase