Principal Statistical Programmer

🔥 2 minutes ago

☕ Washington – Remote

☕ Washington – Remote

💵 $154.2k - $177.7k / year

⏰ Full Time

🔴 Lead

🖥 Software Engineer

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Immunome, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Immunome, Inc. is a clinical-stage oncology company dedicated to improving outcomes for cancer patients through the development of innovative therapeutic candidates. With a focus on targeted therapies, Immunome integrates rigorous scientific research to create first-in-class and best-in-class treatments. Their pipeline includes several promising drug candidates, including antibody drug conjugates and radioligand therapies aimed at addressing high unmet medical needs in oncology.

📋 Description

• 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

• 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

• 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

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