Overview
Remote
$65 - $70
Contract - Independent
Contract - W2
Contract - 18 Month(s)
Skills
CDISC
R
SAS
SDTM
Pivotal
Regulatory Compliance
ADaM
Data Analysis
Python
Reporting
Macros
Job Details
Statistical Programmer Anywhere in US EST time zone- candidate need to work in EST time
Key responsibilities
- At least 5 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
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