Clinical Outcomes Solutions

Senior Statistical Programmer

Clinical Outcomes Solutions

full-time

Posted on:

Location: 🇮🇳 India

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Job Level

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

Requirements

  • 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
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