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Principal Statistical Programmer

Immunome, Inc.

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)