Senior Statistical Programmer

Clinical Outcomes Solutions

full-time

Posted on: 9/3/2025

Origin: • 🇮🇳 India

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Senior

About the role

Working fully embedded within a pharmaceutical client as a Senior Statistical Programmer supporting Phase I-IV clinical trials
Leverage advanced SAS programming skills and proficiency in CDISC SDTM & ADaM to generate and validate datasets, analysis files, and TLFs
Perform data manipulation, analysis and reporting of clinical trial data (safety and efficacy, ISS/ISE)
Production and QC/validation programming and generating complex ad-hoc reports
Create and review submission documents and eCRTs and support submissions
Communicate with internal cross-functional teams and client for project specifications, status, issues or inquiries
Perform lead duties when called upon and collaborate within globally dispersed teams

Bachelor’s degree in Statistics, Computer Science, Mathematics, etc.
At least 8 years of SAS programming working with clinical trial data with a bachelor’s degree (or at least 6 years with a master’s degree)
Study lead experience, preferably juggling multiple projects simultaneously
Strong SAS data manipulation, analysis and reporting skills
Solid experience implementing the latest CDISC SDTM / ADaM standards
Strong QC / validation skills
Good ad-hoc reporting skills
Proficiency in Efficacy analysis
Familiarity with drug development life cycle and manipulation, analysis and reporting of clinical trials’ data
Submissions experience utilizing define.xml and other submission documents
Experience supporting immunology, respiratory or oncology studies is a plus
Excellent analytical & troubleshooting skills
Ability to provide quality output and deliverables under challenging timelines
Ability to work effectively in a globally dispersed team with cross-cultural partners