Associate Director / Director, Biostatistics

Immunomeinc; Bothell (WA); On-site; USD 200,850 - 227,316; Full time

Job summary

Immunomeinc is seeking an Associate Director of Biostatistics in Bothell, Washington to provide statistical support for clinical studies and collaborate cross-functionally. You will apply statistical expertise to study design, analysis plans, and regulatory issues while managing statistical deliverables.

The ideal candidate will have a PhD or Master’s in a related field, significant biostatistics experience, and prior oncology clinical trial experience is preferred. Estimated salary ranges from $200,850 to $227,316 USD annually.

Qualifications

• Minimum of 6 years (with a PhD) or 8 years (with a Master’s) of biostatistics experience.
• Minimum of 2 years of leadership or people-management experience is preferred.

Responsibilities

• Apply rigorous statistical expertise to study design, statistical analysis plans, and interpretation of results.
• Provide strategic statistical input into clinical development plans.
• Plan, deliver, and communicate statistical analyses and scientific reports.

Skills

Prior oncology clinical trial experience

Statistical programming languages (e.g., SAS, R)

Strong verbal and written communication skills

Strong problem-solving skills

Education

PhD or Master’s in Biostatistics, Statistics, or related field

Job description

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 submitted to the U.S. FDA; IM‑1021, a clinical-stage ROR1 ADC; IM‑3050, an IND‑cleared FAP‑targeted radiotherapy; and IM‑1617, an IND‑cleared solid tumor ADC. We are also advancing a broad portfolio of early‑stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

The Associate Director of Biostatistics provides statistical support to clinical studies, including 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 for publication and presentation.

Responsibilities

• Apply rigorous statistical expertise to study design, statistical analysis plans, interpretation of results, project development plans, and regulatory issues.
• Provide strategic statistical input into clinical development plans and study‑level decision‑making, anticipating 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 and scientific presentations.
• Own the timeliness and quality of study‑ and submission‑level statistical deliverables on assigned projects. For outsourced studies, manage vendors and monitor their performance and adherence to project timelines.
• Ensure all study‑ and project‑level statistical activities are conducted in compliance with relevant regulatory requirements (e.g., 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 (e.g., clinical development, clinical data management, statistical programming) to provide statistical support and help identify and resolve data issues.
• Develop and lead initiatives in process improvement, training, and standard development.
• Support ad‑hoc analyses and develop and validate programs for data analysis, reporting, and visualization.

Qualifications

• PhD or Master’s in Biostatistics, Statistics, or a related field.
• Minimum of 6 years (with a PhD) or 8 years (with a Master’s) of biostatistics experience supporting clinical trials in the pharmaceutical, biotech, or CRO industry, or equivalent.
• Minimum of 2 years of leadership or people‑management experience is preferred.

Knowledge and Skills

• Prior oncology clinical trial experience, including familiarity with standard response criteria (e.g., RECIST 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., NDA, BLA) is a strong plus.
• Experience managing CROs and external statistical vendors, including oversight of outsourced statistical deliverables, is a plus.
• Proficiency in statistical programming languages (e.g., SAS, R); experience using simulation to support trial design is a plus.
• Knowledge of CDISC data standards (SDTM and ADaM).
• Knowledge of drug submission requirements and relevant ICH and FDA/EMA guidelines, including the ICH E9(R1) estimand framework.
• Strong 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 proven ability to manage multiple competing priorities.

Washington State Pay Range

$200,850 — $227,316 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.

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).