Senior Statistical Programmer Consultant (Oncology)
New
Based in United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 8–12+ years
- Required Skills
- R
Requirements
- 8–12+ years of statistical programming experience in pharma, biotech, or CRO settings.
- Expert-level proficiency in SAS programming.
- Strong familiarity with R.
- Deep understanding of CDISC standards, including SDTM and ADaM implementation.
- Significant experience supporting oncology clinical trials, including hematologic or solid tumor studies.
- Proven experience preparing regulatory submission packages and submission-ready outputs.
- Strong cross-functional communication skills and ability to collaborate with scientific and regulatory teams.
- Ability to manage multiple studies, timelines, and deliverables in a fast-paced environment.
- Experience with clinical data analysis, derivations, and complex dataset programming.
Responsibilities
- Lead end-to-end statistical programming for oncology studies, including SDTM and ADaM dataset development in compliance with CDISC standards.
- Produce and validate Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
- Ensure traceability, accuracy, and quality control across all programming deliverables and analysis datasets.
- Collaborate with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs teams to support study execution and submissions.
- Oversee and coordinate with CROs and external vendors to ensure adherence to programming standards and timelines.
- Support integrated analyses such as ISS and ISE, as well as responses to regulatory queries and data requests.
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