Immunome, Inc. · 13 hours ago
Senior Director, Biostatistics
Immunome is a clinical-stage targeted oncology company committed to developing innovative cancer therapies. The Senior Director, Biostatistics will lead biostatistical activities across clinical development programs, ensuring statistical excellence and collaboration with various departments to support oncology programs.
BiopharmaBiotechnologyMedicalPharmaceutical
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
Qualification
Required
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
Proficiency in statistical programming tools such as SAS, R, or equivalent
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
Preferred
Experience with ADCs, radioligand therapies, or targeted oncology preferred
Company
Immunome, Inc.
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.
H1B Sponsorship
Immunome, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Public CompanyTotal Funding
$998.85MKey Investors
JPEO-CBRNDU.S. Department of DefenseRobin Hood Ventures
2025-12-16Post Ipo Equity· $400M
2025-01-29Post Ipo Equity· $150M
2024-02-13Post Ipo Equity· $230M
Recent News
2026-01-09
BioWorld Financial Watch
2025-12-19
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