Biostatistics

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

The Associate Director / Director, Biostatistics provides statistical support to clinical studies, including the design, analyses, and interpretation of clinical trials. This position collaborates closely with cross-functional teams and provides scientifically rigorous statistical expertise on projects and protocols in support of clinical development and for publication and presentation.  

Responsibilities

• Apply rigorous statistical expertise to study design, statistical analysis plans, interpretation of results, project development plans, and regulatory issues.
• Provide strategic statistical input into clinical development plans and study-level decision-making, anticipating downstream regulatory and data implications to inform study design and overall development strategy.
• Plan, deliver, and communicate statistical analyses and scientific reports, including clinical trial and exploratory analyses, and support publications and scientific presentations.
• Own the timeliness and quality of study- and submission-level statistical deliverables on assigned projects. For outsourced studies, manage vendors and monitor their performance and adherence to project timelines.
• Ensure all study- and project-level statistical activities are conducted in compliance with relevant regulatory requirements (e.g., FDA regulations).
• Contribute to interactions with regulatory authorities (e.g., FDA, EMA), including statistical input for regulatory meetings, responses to health authority questions, and preparation for advisory committee meetings.
• Collaborate with internal partners (e.g., clinical development, clinical data management, statistical programming) to provide statistical support and help identify and resolve data issues.
• Develop and lead initiatives in process improvement, training, and standard development.
• Support ad hoc analyses and develop and validate programs for data analysis, reporting, and visualization.