Associate Director, Biostatistics
Immunome, Inc.
June 24, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Position Overview
The Associate Director of Biostatistics provides statistical support to clinical studies, including the design, analyses, and interpretation of clinical trials. Collaborates with cross-functional teams and provides scientifically rigorous statistical expertise to support clinical development and for publication and presentation.
Responsibilities
- Apply rigorous statistical expertise to study design, SAPs, interpretation of results, project development plans, and regulatory issues.
- Provide strategic statistical input into clinical development plans and study-level decision-making.
- Plan, deliver, and communicate statistical analyses and scientific reports; support publications and scientific presentations.
- Own the timeliness and quality of study- and submission-level statistical deliverables; manage vendors for outsourced studies.
- Ensure statistical activities comply with relevant regulatory requirements (e.g., FDA regulations).
- Contribute to interactions with regulatory authorities (e.g., FDA, EMA), including statistical input for meetings and responses.
- Collaborate with internal partners (clinical development, clinical data management, statistical programming) to resolve data issues.
- Develop and lead initiatives in process improvement, training, and standard development.
- Support ad hoc analyses and develop/validate programs for data analysis, reporting, and visualization.
Qualifications
- PhD or Master’s in Biostatistics, Statistics, or related field.
- 6+ years (PhD) or 8+ years (Master’s) biostatistics experience supporting clinical trials (pharma/biotech/CRO) or equivalent.
- 2+ years leadership/people-management preferred.
Knowledge & Skills (Required/Preferred)
- Oncology clinical trial experience (e.g., RECIST 1.1; OS/PFS/ORR; survival/time-to-event; group sequential/adaptive designs).
- Strong plus: regulatory submission support (NDA/BLA).
- Proficiency: SAS or R; simulation for trial design (plus).
- CDISC SDTM/ADaM knowledge.
- ICH and FDA/EMA guideline knowledge, including ICH E9(R1) estimand framework.
- Strong communication, problem-solving, attention to detail, and ability to manage multiple priorities.
Pay Range
- $200,850 - $227,316 USD
The Associate Director of Biostatistics provides statistical support to clinical studies, including the design, analyses, and interpretation of clinical trials. Collaborates with cross-functional teams and provides scientifically rigorous statistical expertise to support clinical development and for publication and presentation.
Responsibilities
- Apply rigorous statistical expertise to study design, SAPs, interpretation of results, project development plans, and regulatory issues.
- Provide strategic statistical input into clinical development plans and study-level decision-making.
- Plan, deliver, and communicate statistical analyses and scientific reports; support publications and scientific presentations.
- Own the timeliness and quality of study- and submission-level statistical deliverables; manage vendors for outsourced studies.
- Ensure statistical activities comply with relevant regulatory requirements (e.g., FDA regulations).
- Contribute to interactions with regulatory authorities (e.g., FDA, EMA), including statistical input for meetings and responses.
- Collaborate with internal partners (clinical development, clinical data management, statistical programming) to resolve data issues.
- Develop and lead initiatives in process improvement, training, and standard development.
- Support ad hoc analyses and develop/validate programs for data analysis, reporting, and visualization.
Qualifications
- PhD or Master’s in Biostatistics, Statistics, or related field.
- 6+ years (PhD) or 8+ years (Master’s) biostatistics experience supporting clinical trials (pharma/biotech/CRO) or equivalent.
- 2+ years leadership/people-management preferred.
Knowledge & Skills (Required/Preferred)
- Oncology clinical trial experience (e.g., RECIST 1.1; OS/PFS/ORR; survival/time-to-event; group sequential/adaptive designs).
- Strong plus: regulatory submission support (NDA/BLA).
- Proficiency: SAS or R; simulation for trial design (plus).
- CDISC SDTM/ADaM knowledge.
- ICH and FDA/EMA guideline knowledge, including ICH E9(R1) estimand framework.
- Strong communication, problem-solving, attention to detail, and ability to manage multiple priorities.
Pay Range
- $200,850 - $227,316 USD