Senior Statistical Programmer – FSP

Posted 59mins ago

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Job Description

Senior Statistical Programmer using SAS and CDISC standards for a global pharmaceutical client. Supporting clinical-trial data analysis, validation, reporting, and submissions.

Responsibilities:

  • Perform data manipulation, analysis and reporting of clinical trial data, including safety and efficacy (ISS/ISE), using SAS programming
  • Generate and validate SDTM and ADaM datasets/analysis files and tables, listings, and figures (TLFs)
  • Perform production and QC/validation programming
  • Generate complex ad-hoc reports using raw data
  • Apply strong understanding and experience of efficacy analysis
  • Create and review submission documents and eCRTs
  • Communicate with internal cross-functional teams and clients regarding project specifications, status, issues, and inquiries
  • Perform lead duties when called upon
  • Contribute as a team player and meet deadlines
  • Adapt to changing priorities

Requirements:

  • Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related field
  • At least 7+ years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent
  • At least 6 years of related experience with a master’s degree or above
  • Strong SAS data manipulation, analysis and reporting skills
  • Solid experience implementing CDISC SDTM / ADaM standards
  • Strong QC / validation skills
  • Good ad-hoc reporting skills
  • Proficiency in efficacy analysis
  • Familiarity with the drug development life cycle and clinical-trial data manipulation, analysis and reporting
  • Submissions experience using define.xml and other submission documents
  • Ability to prioritize workloads
  • Excellent analytical and troubleshooting skills
  • Ability to provide quality output and deliverables within challenging timelines
  • Ability to work effectively in a globally dispersed team with cross-cultural partners
  • Experience with epilepsy studies would be a plus

Benefits:

  • Consistent training, development and support
  • Significant professional growth opportunities
  • Fully remote work option stated in the position overview