Senior Manager, Statistical Programming
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Job Description
Senior statistical programmer supporting clinical-trial analyses and regulatory submissions. Advancing Immunome’s targeted oncology therapies through SAS and CDISC programming.
Responsibilities:
- 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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