Remote Contract Statistical Programmer (SAS/R, CDISC)

Iovance Biotherapeutics, Inc.; United States; Remote; USD 70,000 - 80,000; Full time

Benefits offered by this job

Remote-friendly

Job summary

Iovance Biotherapeutics seeks a Contract Statistical Programmer to develop, validate, and maintain SAS/R programs for SDTM/ADaM datasets and TLFs, in a GxP-compliant setting. You will work with statisticians, data management, and cross-functional teams to ensure timely datasets and reports for regulatory submissions.

The ideal candidate has a strong statistics/quantitative background, oncology experience, and a track record in CDISC standards, TLFs, and regulatory submissions.

Qualifications

• Master’s or higher in math, stats, CS, biostatistics, data science, or related field with 5+ years experience.
• Strong proficiency in SAS and/or R for clinical trial analysis.
• Knowledge of CDISC standards (SDTM/ADaM/Define-XML) and regulatory submissions.
• Experience producing TLFs and SDTM/analysis datasets in pharma/biotech/CRO.
• Experience in oncology trials or cell/gene therapy programs.
• Excellent analytical and communication skills; ability to work independently.

Responsibilities

• Develop, validate, and maintain SAS and/or R programs for SDTM/ADaM datasets and TLFs.
• Support analyses for safety reports, publications, CSRs, and regulatory submissions.
• Ensure programming activities comply with FDA 21 CFR Part 11, GxP, SOPs.
• Collaborate with statisticians, data managers, and clinical teams to define specs.
• Perform quality control and review of programs and outputs.
• Develop reusable macros and automation to improve efficiency.
• Explore AI/ML-based automation to enhance workflows.
• Contribute to data specifications and maintain audit-ready documentation.

Skills

SAS

R

Analytical thinking

Communication skills

Education

Master’s degree in a quantitative field

Bachelor’s degree in a quantitative field

Tools

SAS

R

CDISC SDTM/ADaM

Define-XML

Job description

Iovance Biotherapeutics seeks a Contract Statistical Programmer to develop, validate, and maintain SAS/R programs for SDTM/ADaM datasets and TLFs, in a GxP-compliant setting. You will work with statisticians, data management, and cross-functional teams to ensure timely datasets and reports for regulatory submissions.

The ideal candidate has a strong statistics/quantitative background, oncology experience, and a track record in CDISC standards, TLFs, and regulatory submissions.