Remote Contract Statistical Programmer – SAS/R, CDISC

Iovance Biotherapeutics; San Carlos (CA); On-site; USD 70,000 - 80,000; Full time

Job summary

Iovance Biotherapeutics is seeking a Contract Statistical Programmer to develop, validate, and maintain SAS and/or R programs for SDTM/ADaM datasets and TLFs in a GxP environment. You will work with statisticians, data managers, and cross-functional teams to deliver high-quality analyses for regulatory submissions.

The role requires a strong foundation in statistics or quantitative sciences, experience with CDISC standards, and familiarity with FDA/ICH guidelines.

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 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 pharma/biotech/CRO settings
• Experience with oncology clinical trials or cell/gene therapy programs
• Strong analytical, problem-solving, and communication skills
• Familiarity with FDA and ICH GxP programming practices
• Attention to detail and ability to manage multiple priorities independently in a remote environment

Responsibilities

• Develop, validate, and maintain SAS and/or R programs for SDTM/ADaM datasets and TLFs
• Support analyses for safety reports, CSR, regulatory submissions and ad hoc analyses
• Ensure programming complies with FDA 21 CFR Part 11 and GxP
• Collaborate with statisticians and data teams to define analysis specs
• Perform QC and review of programs and outputs
• Develop reusable macros, templates, and automation tools
• Explore AI-based tools to enhance programming workflows
• Contribute to data specs development and documentation
• Maintain audit-ready documentation and regulatory readiness
• Uphold Iovance Biotherapeutics' values and policies

Skills

SAS

R

CDISC SDTM/ADaM

Define-XML

TLFs

Education

Master's degree in statistics or related field

Bachelor's degree in mathematics, statistics, CS

Tools

AI agents/tools

Job description

Iovance Biotherapeutics is seeking a Contract Statistical Programmer to develop, validate, and maintain SAS and/or R programs for SDTM/ADaM datasets and TLFs in a GxP environment. You will work with statisticians, data managers, and cross-functional teams to deliver high-quality analyses for regulatory submissions.

The role requires a strong foundation in statistics or quantitative sciences, experience with CDISC standards, and familiarity with FDA/ICH guidelines.