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Protocol Intelligence
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Job Description
Structured overview of role & requirementsAbout This Role
Support clinical trial activities by contributing to study design, protocols, and case report forms.
Develop and review statistical analysis plans, programming statistical procedures, and creating deliverables like reports, tables, and graphs primarily using SAS.
Lead database review activities and develop specifications for derived variables ensuring data compliance and quality.
Minimum Requirements
4+ years of statistical programming experience in pharmaceutical, biotechnology, or CRO industry.
Strong hands-on SAS programming skills for clinical trial statistical analyses.
Basic knowledge or training in R programming.
Comprehensive understanding of CDISC standards (SDTM and ADaM) and experience with Pinnacle 21 for CDISC compliance checks.
Ideal Candidate Profile
Experienced in programming and validating production-quality statistical code in clinical research settings.
Capable of collaborating effectively with cross-functional teams for clinical trial data analysis and deliverables.
Familiarity with advanced statistical procedures such as repeated measures and survival analysis programming using SAS.