Senior Clinical SAS programmer with Pharma experience -Remonte-W2 -Contract

Biogensys is currently hiring a Senior SAS programmer with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available.

Statistical Programmer II: Pharma experience/Remote

• At least 7-8 years of experience in ADaM/TLF.
• Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverables
• Develop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in production side.
• Collaborate with statisticians and data managers to define dataset specifications and outputs
• Ensure compliance with internal SOPs, CDISC standards, and regulatory requirements
• Conduct quality control checks and peer reviews of programming code and study outputs
• Support submission activities including eCTD and regulatory responses as needed
• Document programming activities and maintain clear audit trails
• Has experience on the safety ADaM/TLF production side instead of validation side
• Has experience leading pivotal studies (phase 2, phase 3 studies).
• Strong proficiency in SAS programming (Base, Macro, SQL); familiarity with R or Python is a plus
• Develop study protocols, statistical analysis plans (SAPs), and define analysis datasets
• Understanding of CDISC standards (SDTM, ADaM)
• Knowledge of FDA/EMA regulatory requirements and e-submission standards
• Excellent problem-solving and communication skills
• Experience with oncology, rare diseases, or global trials
• Exposure to automation tools or advanced data visualization techniques

• Ability to mentor junior programmers or lead small projects

Education:

• Bachelor s or master s in computer science or Related Field