Senior Director, Statistical Programming

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.

Company Overview

Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies, targeted effectors, radioligand therapies and antibody drug conjugates (ADCs). We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.

Position Overview

The Senior Director, Statistical Programming 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.

The Senior Director of Statistical Programming provides leadership and oversight across clinical programs within Statistical Programming function.  This position will require managing programming resources, assisting in development of Programming infrastructure and process, providing technical support and guidance for regulatory submissions while adhering to CDISC standards and submission requirements. This person will be required to collaborate closely with cross-functional teams to help drive and adhere to major submission deliverable timelines. 

Responsibilities

• Provide leadership and line management to Statistical Programming function, ensuring focus on business priorities and values
• Provide management and oversight of statistical programming resources including FTEs, contractors and CROs involved in late-stage studies.
• Ensure quality and timeliness of statistical analysis, reporting, and regulatory submission deliverables. Provide hands-on programming, if required, of critical ADAMs and TLFs that form a part of regulatory submissions
• Demonstrate strong technical expertise to promote best practices related programming environments, technology and programming skillsets.
• Develop and ensure conformation to Programming SOPs and Work Practice guidelines
• Maintain strategy for capability and skill development to meet current and future requirements.
• Maintain an environment to foster creativity and transparency, and a framework for continuous improvement.
• Drive standardization and innovation to ensure future fitness of the organization.

Qualifications

• PhD or Master in Biostatistics, Statistics, or a related field.
• A minimum of 15 years of experience working in the pharmaceutical, biotech, or CRO industry. A minimum of five years of leadership experience is strongly preferred.
• Significant oncology is experience is required.

Knowledge and Skills

• Track record of leading and overseeing global regulatory submissions in oncology
• Proficiency in statistical programming languages (e.g., SAS, R).
• Solid experience with reporting process, regulatory requirements, and software development life cycle.
• Strong leadership, interpersonal, and organizational skills, and ability to work within cross-functional teams
• Strong communication skills with ability to align the company on complex technical decisions.
• Proven experience in developing and leading high-performing teams.
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, identify and resolve issues, and positively influence the team.
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment

Washington State Pay Range$262,648—$294,125 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.