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Ofis
Bothell, Washington, United States
Yayınlandı · 20.09.2026
Greenhouse (US)

# Associate Director / Director, Biostatistics

Immunome, Inc.

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.&nbsp;&nbsp; Responsibilities Apply&nbsp;rigorous statistical&nbsp;expertise&nbsp;to&nbsp;study design, statistical analysis plans, interpretation&nbsp;of&nbsp;results, project development plans,&nbsp;and&nbsp;regulatory issues. Provide strategic statistical input into clinical development plans and study-level decision-making,&nbsp;anticipating&nbsp;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&nbsp;and scientific presentations. Own&nbsp;the timeliness and quality of study- and submission-level statistical deliverables on assigned projects. For outsourced studies, manage&nbsp;vendors&nbsp;and&nbsp;monitor&nbsp;their performance and adherence to&nbsp;project timelines. Ensure&nbsp;all study- and project-level statistical activities are conducted in compliance with relevant regulatory requirements&nbsp;(e.g.,&nbsp;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&nbsp;(e.g.,&nbsp;clinical&nbsp;development, clinical data management,&nbsp;statistical programming) to provide statistical support&nbsp;and help&nbsp;identify&nbsp;and resolve&nbsp;data issues. Develop and lead&nbsp;initiatives in process improvement,&nbsp;training,&nbsp;and standard development. Support ad hoc analyses and develop and validate&nbsp;programs for data analysis, reporting,&nbsp;and visualization.&nbsp;&nbsp; Qualifications PhD or&nbsp;Master’s&nbsp;in Biostatistics, Statistics, or&nbsp;a related&nbsp;field. A minimum of&nbsp;6 years (with a PhD) or&nbsp;8&nbsp;years&nbsp;(with a Master's)&nbsp;of&nbsp;biostatistics&nbsp;experience&nbsp;supporting clinical trials&nbsp;in the pharmaceutical, biotech, or CRO industry, or&nbsp;equivalent. A minimum of 2 years&nbsp;of leadership&nbsp;or people-management&nbsp;experience is&nbsp;preferred.&nbsp;&nbsp; Knowledge and Skills Prior&nbsp;oncology&nbsp;clinical trial&nbsp;experience, including familiarity with standard response criteria (e.g., RECIST&nbsp;1.1), oncology endpoints (e.g., overall survival, progression-free survival, objective response rate), and associated statistical methodology (e.g., survival/time-to-event analysis, group sequential and adaptive designs). Experience supporting regulatory submissions (e.g.,&nbsp;NDA, BLA)&nbsp;is&nbsp;a strong plus. Experience managing CROs and external statistical vendors, including oversight of outsourced statistical deliverables, is a plus. Proficiency&nbsp;in statistical programming languages (e.g., SAS, R);&nbsp;experience using simulation to support trial design is&nbsp;a plus. Knowledge of CDISC data standards (SDTM and ADaM). Knowledge of drug submission requirements&nbsp;and&nbsp;relevant ICH and FDA/EMA guidelines, including the ICH E9(R1)&nbsp;estimand&nbsp;framework. Strong&nbsp;verbal and written communication skills, including the ability to convey complex statistical concepts to cross-functional, non-statistical audiences. Strong problem-solving skills and the ability to work both independently and collaboratively in a fast-paced environment. Strong attention to detail and a&nbsp;proven ability to manage&nbsp;multiple&nbsp;competing priorities.&nbsp; &nbsp; Washington State Pay Range
• Associate Director: $200,850 - $227,316 Washington State Pay Range
• Director: $235,000 - $263,700 &nbsp;Washington State Pay Range$200,850&mdash;$263,700 USDE/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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