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, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets.
Position Overview
The Senior Director, Biostatistics will serve as the strategic and technical leader for biostatistical activities across Immunome’s clinical development programs. This role will be responsible for establishing and executing statistical strategy, providing leadership in study design and analysis, and ensuring statistical excellence in regulatory submissions. The successful candidate will partner cross-functionally with Clinical Development, Data Management, Regulatory Affairs, and Clinical Operations to ensure the highest scientific and statistical standards are applied to Immunome’s oncology programs.
Responsibilities
- Provide statistical leadership and strategic input for Immunome’s clinical development programs, including early- and late-phase oncology studies.
- Lead statistical design and analysis of clinical trials, including sample size estimation, randomization, and endpoint selection.
- Oversee statistical deliverables for regulatory submissions, including protocol development, statistical analysis plans, and clinical study reports.
- Collaborate with Clinical, Regulatory, and Data Management functions to ensure data integrity, quality, and alignment with study objectives.
- Provide statistical guidance on adaptive designs, interim analyses, and innovative methodologies relevant to Immunome’s therapeutic platforms (including ADCs and radioligands).
- Manage and mentor biostatistics staff and external statistical vendors to ensure timely, high-quality deliverables.
- Participate in regulatory interactions (FDA, EMA, etc.) and contribute to preparation of briefing documents, responses, and statistical justifications.
- Develop and maintain statistical standards, processes, and best practices aligned with ICH E9 and CDISC standards.
Qualifications
- Ph.D. in Biostatistics, Statistics, or a related quantitative discipline.
- 12+ years of biostatistics experience in the pharmaceutical or biotechnology industry, with at least 5 years in oncology drug development.
- Demonstrated leadership experience managing biostatistics teams and vendors.
- Proven track record of contributing to successful INDs, NDAs, or BLAs.
- Strong understanding of clinical trial design, regulatory guidance, and modern statistical methodologies in oncology.
- Experience with ADCs, radioligand therapies, or targeted oncology preferred.
- Proficiency in statistical programming tools such as SAS, R, or equivalent.
Knowledge and Skills
- Deep expertise in statistical methods for clinical trials, including clinical trial simulation, survival analysis, longitudinal data, and multiplicity adjustments.
- Strong communication and collaboration skills; ability to explain complex statistical concepts to non-statistical audiences.
- Strategic mindset with hands-on ability to execute and problem-solve in a fast-paced, innovative environment.
- High ethical standards and scientific rigor, consistent with Immunome’s commitment to improving cancer patient outcomes.
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).
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What We Do
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class 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-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. 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.
