Senior Manager, Statistical Programming

🔥 11 minutes ago

☕ Washington – Remote

☕ Washington – Remote

💵 $175.5k - $201k / year

⏰ Full Time

🟠 Senior

👔 Manager

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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

• Lead statistical programming activities for 1 or 2 assigned clinical studies across the full study lifecycle • Develop and/or review programming specifications based on the Statistical Analysis Plan • 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 • Manage study programming timelines, coordinate 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 • Oversee CRO statistical programming activities and review outputs for accuracy, compliance, and timely delivery • Validate CRO-generated datasets, TLFs, and submission components using tools such as Pinnacle 21 • Develop and maintain SAS macros, utilities, programming standards, and reusable tools • Ensure adherence to CDISC standards, regulatory expectations, departmental SOPs, and best practices • Mentor junior programmers or contractors • Contribute to departmental initiatives, process improvements, and cross-functional projects

🎯 Requirements

• A master’s degree (or higher) in Statistics, Computer Science or other closely related field to programming • Minimum 6+ years of relevant pharmaceutical/biotech industry experience • Solid knowledge of statistical programming principles, clinical trials process and regulatory requirements • Excellent verbal/written and interpersonal skills required to communicate and collaborate effectively with cross-functional teams • 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

🏖️ 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

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