Iovance Biotherapeutics
Contract Statistical Programmer
- Confirmed live in the last 24 hours
- No salary listed
- Mid level
- Contract
- Remote
- 5+ yrs exp
- Added 2 months ago
About this role
Iovance Biotherapeutics seeks a skilled Contract Statistical Programmer to contribute to clinical development programs. This remote role involves developing, validating, and maintaining SAS/R programs for SDTM, ADaM datasets, and TLFs, ensuring compliance with CDISC standards and regulatory guidelines. The ideal candidate possesses strong programming skills and a solid understanding of clinical data analysis within the biotechnology sector.
What you'll do
- Develop and validate SAS/R programs for SDTM and ADaM datasets.
- Create TLFs and support statistical analyses for various reports.
- Ensure compliance with FDA 21 CFR Part 11, GxP, and internal SOPs.
- Collaborate with cross-functional teams to resolve data issues.
- Perform quality control and review of statistical programs.
- Develop and maintain reusable macros and automation tools.
What they're looking for
- SAS programming
- R programming
- CDISC (SDTM, ADaM, Define-XML)
- Clinical trial data analysis
- Regulatory submission requirements
- Problem-solving
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Iovance Biotherapeutics
- Industry
- Biotech & Pharma
Likely interview questions
- Describe your experience with creating SDTM datasets and TLFs.
- How familiar are you with CDISC standards and regulatory submission requirements?