Principal Statistical Programmer
Immunome, Inc.
- Remote · United States
- Remote
- Lead/Staff
- Posted
Skills
Required
- CDISC
- SAS
- SDTM
- statistical programming principles
- GCP
- EDC systems
Preferred
- NDA submission
- statistical programming
- Data Management
- SAS programming
- TLFs
- complex programming
- statistical programming standards
- Statistical Analysis
- As a Principal Statistical Programmer, you will serve as a senior technical expert within the individual contributor career track.
- This role may also collaborate cross-functionally with Biostatistics, Data Management, Clinical Development, and other functions.
About Immunome, Inc.
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.
Join Our Experienced, Passionate Team
Working at Immunome gives you the opportunity to make a difference in the lives of cancer patients, contribute to developing best-in-class targeted cancer therapies, and work with some of the brightest and most experienced minds in antibody-drug conjugate (ADC) development.
Immunome’s office is charged with the collective excitement and passion of people working together to develop life-changing cancer medicines. Our team thrives in an innovative, collaborative environment where employees are empowered to do their best work.
Responsibilities
- You will independently develop, validate, document, and deliver high-quality SAS programming deliverables supporting the analysis and reporting of clinical trial results.
- The role will be accountable for the accuracy, quality, traceability, and reproducibility of its code and outputs.
- You will provide technical leadership on complex programming matters and serve as a technical resource to other programmers.
- This role will support the submission-readiness of study data packages by applying CDISC standards, applicable regulatory guidance, and internal standards.
- Working closely with Programming leadership, the role will contribute technical expertise to the continuous improvement of statistical programming standards, processes, tools, and infrastructure.
- Develop and/or view programming specifications based on the Statistical Analysis Plan and oversee the creation, validation, and delivery of CDISC-compliant SDTM and ADaM datasets, TLFs, Define.xml, and reviewer guides.
- Provide hands-on SAS programming support for key analyses, data exploration, ad hoc requests, and internal or regulatory deliverables, as needed.
- Adhere to
- study
- programming timelines and evaluate dependencies, proactively identif y risks
- and ensur
e
- alignment with cross-functional study plans and key milestones.
- Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Safety teams to review requirements, refine specifications, and resolve data or programming issues.
- Review Data Management Plans, case report forms, data transfer specifications, external/vendor data specifications, and validation-related documentation to ensure data quality and downstream programming readiness.
- Validate CRO-generated SDTM/
- ADaM
- datasets, TLFs, and submission components using industry-standard tools such as Pinnacle 21 to access CDISC compliance and support resolution of identified issues
Lead technical initiatives to develop and maintain
- SAS macros, utilities, and programming standards, and reusable tools to improve efficiency, consistency, and scalability across studies.
- Ensure adherence to CDISC standards, regulatory expectations, departmental SOPs, and best practices for statistical programming and data traceability.
- Contribute to departmental initiatives, process improvements, and cross-functional projects beyond assigned study responsibilities.
- to lead statistical programming activities for assigned clinical studies working closely with Programming leadership.
Requirements
- master’s
- degree (or higher) in Statistics, Computer Science or other closely related field to programming with minimum
4
- + years of relevant pharmaceutical/biotech industry experience.
- Requires solid knowledge of statistical programming principles, clinical trial process, and regulatory requirements.
- Dynamic self-starter; agile learner; strategic and creative thinker.
- Demonstrated strong problem solving and risk-mitigation skills.
- Excellent verbal/written and interpersonal skills required to communicate and collaborate effectively with cross-functional teams (clinical operations, Scientists, Medical Monitors and Statisticians) in face-to-face conversation, by telephone, and by email.
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
- well-rounded technical skills (SAS, EDC systems, MS Word, Excel, PowerPoint, API based data extracts, ETL principles) and knowledge of industry standards (CDISC, SDTM, CDASH, ADaM
Preferred
- Prior NDA submission and regulatory agency interaction experience highly desirable.
- Prior Oncology/Hematology experience
- desirable.
Pay
- $154,230
- $177,726 USD
Benefits
- Immunome also offers a comprehensive benefit program for you and your family, including:
- Medical, dental, and vision insurance coverage for employees and their dependents, including 100% company-paid medical premiums for employees
A 401(k) with employer match
- Employer-paid life insurance, short- and long-term disability insurance, and AD&D
- Paid time off, company holidays, and a week-long winter break between Christmas and New Years.
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)
