Principal Statistical Programmer

Immunome, Inc.

. Independently develop, validate, document, and deliver SAS programming deliverables for clinical trial analysis and reporting .

Posted 11/7/2026full-timeRemote • Washington • United StatesLead💰 $154,230 - $177,726 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in SAS programming for clinical trial analysis, ensuring compliance with CDISC standards and regulatory requirements while effectively collaborating with cross-functional teams. Possesses strong problem-solving abilities and a solid understanding of statistical programming principles within the pharmaceutical industry.

Highest-signal resume keywords

SAS ProgrammingCDISC ComplianceStatistical Analysis PlansRegulatory RequirementsClinical Trial Process

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

SASStatistical Programming PrinciplesCDISCSDTMADaMETL PrinciplesAPI-Based Data ExtractsData ValidationProgramming SpecificationsStatistical Programming Best Practices

Soft Skills

Problem-SolvingRisk MitigationInterpersonal SkillsCollaborationCommunication

Tools & Technologies

Pinnacle 21EDC SystemsMS WordMS ExcelMS PowerPoint

Industry Keywords

PharmaceuticalBiotechICH GuidelinesFDA RegulationsGCP RegulationsOncologyHematologyNDA SubmissionClinical OperationsData Management

Tech Stack

Tools & technologies

ETL

About the role

Key responsibilities & impact

Independently develop, validate, document, and deliver SAS programming deliverables for clinical trial analysis and reporting
Develop or review programming specifications based on Statistical Analysis Plans
Oversee 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
Adhere to study programming timelines, evaluate dependencies, identify risks, and align with cross-functional study plans and milestones
Collaborate with Biostatistics, Data Management, Clinical Operations, and Safety teams
Review data management plans, case report forms, data transfer specifications, vendor data specifications, and validation documentation
Validate CRO-generated SDTM/ADaM datasets, TLFs, and submission components using tools such as Pinnacle 21
Lead development and maintenance of SAS macros, utilities, programming standards, and reusable tools
Ensure adherence to CDISC standards, regulatory expectations, departmental SOPs, and statistical programming best practices
Contribute to departmental initiatives, process improvements, and cross-functional projects
Potentially lead statistical programming activities for assigned clinical studies

Requirements

What you’ll need

A master’s degree or higher in Statistics, Computer Science or another closely related field to programming
Minimum 4+ years of relevant pharmaceutical/biotech industry experience
Solid knowledge of statistical programming principles, clinical trial process, and regulatory requirements
Good working knowledge of ICH, FDA, and GCP regulations and guidelines
Strong technical skills in SAS, EDC systems, MS Word, Excel, PowerPoint, API-based data extracts, and ETL principles
Knowledge of CDISC, SDTM, CDASH, and ADaM industry standards
Strong problem-solving and risk-mitigation skills
Excellent verbal, written, and interpersonal skills for cross-functional collaboration
Prior NDA submission and regulatory agency interaction experience highly desirable
Prior Oncology/Hematology experience highly desirable

Benefits

Comp & perks

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
Paid parental leave
Opportunity to contribute to developing targeted cancer therapies
Collaborative, innovative work environment