Statistical Programmer - Biopharmaceutical Therapies
SRG · San Mateo County, CA · 1 mo ago
RemoteRemoteScienceContract
Long Term Contract
Full Remote
W2, 1099, C2C
Required Qualifications
- CDISC standards expertise
- SDTM dataset programming
- ADaM dataset creation
- Statistical programming, SAS programming
- Tables, Listings & Figures (TLFs) validation programming
- Mid-to-Senior level experience
- Excellent communication and collaboration skills
- 5+ years of Statistical Programming experience within the pharmaceutical, biotechnology, or CRO industry
- Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, or related field
- Prior experience with label/listing configuration
- Prior experience functioning as both a developer and validation programmer
Key Responsibilities
- Develop and maintain SDTM and ADaM datasets in accordance with CDISC standards
- Program and validate Tables, Listings, and Figures (TLFs) to support clinical study deliverables
- Create submission-ready clinical datasets and supporting documentation
- Perform quality control and independent validation of programming outputs
- Support data package creation and downstream statistical programming activities
- Collaborate with Biostatistics, Data Management, and Clinical teams to ensure timely delivery of study milestones
- Ensure compliance with regulatory and company standards for clinical trial reporting