Associate Director / Director, Biostatistics
Immunome, Inc.Bothell, Washington, United States · Posted 2 months agoDescription
Company Overview
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.
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.
- A 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.
- A 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.
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