Overview
Iovance is seeking a Contract Statistical Programmer to support clinical development programs by developing, validating, and maintaining statistical programming deliverables for clinical studies and regulatory submissions. This role will work closely with statisticians, data management, and other cross-functional teams to ensure high-quality and timely delivery of datasets, tables, listings, and figures in a GxP-compliant environment. The ideal candidate combines strong programming expertise with a solid foundation in statistics or quantitative sciences and thrives in a collaborative, fast-paced biotech setting.
Essential Functions and Responsibilities
- Develop, validate, and maintain SAS and/or R programs for the creation of SDTM, ADaM datasets, and TLFs in accordance with CDISC standards.
- Support statistical analyses for periodic safety reports, publications, conference presentations, IDMC/DSMB reviews, clinical study reports (CSRs), regulatory submissions, health authority requests and other ad hoc analyses and reporting needs.
- Ensure all programming activities comply with FDA 21 CFR Part 11, GxP, and internal SOPs.
- Collaborate with biostatisticians, data managers, and clinical teams to define analysis specifications and resolve data issues.
- Perform quality control and detailed review of statistical programs and outputs.
- Develop and maintain reusable macros, templates, and automation tools to improve programming efficiency.
- Contribute to the evaluation and implementation of emerging technologies and modern programming approaches, including AI-based tools and agents, to enhance statistical programming workflows.
- Participate in development and review programming data specifications.
- Maintain clear, thorough documentation to support audit readiness and regulatory inspection.
Required Education, Skills, and Knowledge
- Master’s degree in mathematics, statistics, computer science, biostatistics, data science or a related quantitative field with 5+ years of relevant industry experience; or bachelor’s degree in mathematics, statistics, computer science, biostatistics, data science or a related quantitative field with 8+ years of relevant industry experience.
- Strong proficiency in SAS and/or R for clinical trial data analysis and reporting.
- Working knowledge of CDISC standards (SDTM, ADaM, Define-XML) and regulatory submission requirements.
- Experience producing TLFs and SDTM/analysis datasets in a pharmaceutical, biotechnology, or CRO setting.
- Experience with oncology clinical trials or cell/gene therapy programs.
- Familiarity with regulatory guidelines (FDA, ICH) and GxP-compliant programming practices.