Contract Statistical Programmer
$145,600–$166,400 year
RemoteUnited States
Job Summary
Develop, validate, and maintain SAS and R programs for SDTM, ADaM datasets, and TLFs per CDISC standards. Support analyses for periodic safety reports, CSRs, regulatory submissions, and ad hoc requests. Ensure all activities comply with FDA 21 CFR Part 11, GxP, and internal SOPs. Collaborate with biostatisticians and data managers to define specifications and resolve data issues. Perform quality control reviews of programs and outputs. Develop reusable macros, templates, and automation tools, including AI-based agents to enhance workflows. Maintain documentation for audit readiness. This remote contract role supports Iovance's tumor infiltrating lymphocyte therapy development programs.
Required Qualifications
- 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
- Strong analytical, problem-solving, and communication skills
- Familiarity with regulatory guidelines (FDA, ICH) and GxP-compliant programming practices
- Excellent attention to detail, problem-solving skills, and the ability to manage multiple priorities independently in a remote environment
Desired Qualifications
- Master's degree in mathematics, statistics, or computer science is strongly preferred
- Hands-on experience developing AI agents or applying AI/ML-based automation tools to streamline data analysis, programming workflows, or reporting processes is a significant plus
- Experience supporting regulatory submissions (NDA, BLA, MAA, or equivalent)
- Familiarity with electronic submission standards (eCTD) and health authority interactions
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