Associate Director, Biostatistics

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, IM-1021, a ROR1 ADC with an active IND, and IM-3050, a FAP-targeted radioligand, which is the subject of an IND expected to be submitted in the first quarter of 2025. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.

Position Overview

The Associate Director for Biostatistics provides important 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

• Provide scientifically rigorous statistical expertise on study design, statistical analysis plans, interpretation and communication of statistical results, project development plans, regulatory issues, and scientific and other product support projects.
• Provide planning, delivery, and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, and exploratory analyses, support for publication activities, and scientific presentations.
• Accountable for timeliness and quality of study / submission level statistical deliverables on assigned projects. For studies with statistical services being outsourced, provide effective vendor management, and monitor vendor performance and ensure compliance with project timelines.
• Ensure all study and project level statistical activities are conducted in compliance with relevant regulatory requirements (e.g., FDA regulations).
• Develop effective collaborations internally (e.g., clinical, clinical data management, clinical programming, statistical programming) to provide statistical support in clinical trials as needed, including inputs for data issues identification, and resolutions.
• Develop and lead initiatives in process improvement, training, and standard development.
• Provide support for ad hoc analyses, and develop and validation programs for data analysis, reporting and visualization.

Qualifications

Knowledge and Skills

Washington State Pay Range

180,000-$209,000 USD

E / E / O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Salary : $180,000 - $209,000