Everest Clinical Research

Senior Statistical Programmer

Everest Clinical Research

full-time

Posted on:

Location Type: Remote

Location: Romania

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Job Level

Senior

About the role

  • Lead efforts in resolving day-to-day work-related issues and problems, ensuring quality of deliverables.
  • Lead assigned projects by applying project management skills and statistical programming techniques.
  • Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE.
  • Perform quality control (QC) review of documents prepared by others.
  • Program and validate SDTM and ADaM datasets following approved dataset specifications.
  • Perform CDISC standard compliant checks on SDTM and ADaM datasets.
  • Generate, review, and resolve Pinnacle 21 validation issues.
  • Perform additional QC checks using company Working Instruction (WI) QC checklists.
  • Perform overall quality/consistency review of statistical TLGs.
  • Create SDTM and ADaM define.xml files.
  • Perform QC review of these files prepared by others.
  • Participate and/or lead programming teams in support of product regulatory submission activities.
  • Learn and maintain expertise in utilities and macros for Statistical Programmers.
  • Develop new macros and utilities.
  • Program and perform QC/validation of complex data integrity checks.
  • Complete job-required and project-specific training.
  • Comply with applicable policies, SOPs, and WIs.
  • Document data and programming information in accordance with corporate SOPs and guidelines.

Requirements

  • A Master’s or Ph.D. degree in Statistics, Biostatistics, Epidemiology, and Computer Sciences, with at least four years’ experience in clinical trial statistical programming OR A Bachelor’s degree in the above fields with at least six years’ experience in clinical trial statistical programming.
Benefits
  • Health insurance
  • Flexible work arrangements

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
statistical programmingSDTMADaMquality controldata validationCDISC standardsmacrosdata integrity checksdefine.xmlproject management
Soft skills
leadershipproblem-solvingcommunicationteam collaborationattention to detail