ClinChoice

Senior/Principal Statistical Programmer Consultant - Oncology

ClinChoice

contract

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Job Level

Senior

About the role

  • Provide oversight development of datasets (SDTMs/ADaMs) in CDISC-compliant format by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists.
  • Generate and/or review SDTM mapping specifications, annotated CRFs, ADaM specifications, define.XML documents, and reviewers’ guides per CDISC and FDA specifications and guidelines.
  • Accountable for oversight of statistical programming deliverables for in-house and outsourced projects.
  • Provide technical leadership, problem-solving of moderate to high complexity, and within project timelines while providing high-quality deliverables.
  • Independently develop SAS or other programs and specifications for production of output to support study needs, including publications, safety reporting, and ad hoc analyses in a timely fashion
  • Demonstrate expertise in SAS language, procedures, and options commonly used in clinical trial reporting, including the Macro language, BASE SAS, SAS/STAT & SAS/GRAPH.
  • Oversee and manage the work of other junior programmers.
  • Develop and/or validate standard macros to automate output production.
  • Adhere to company SOPs and department guidelines.
  • Work concurrently on multiple projects
  • Troubleshoot technical and project issues.
  • Help with the infrastructure development of the department.
  • Communicate effectively with internal cross-functional groups and external partners.

Requirements

  • BS/BA degree in a related discipline
  • At least 8 – 10 years of experience in statistical programming with clinical data and SAS.
  • Experience in Oncology therapeutic area is must.
  • Strong SAS programming skills required with proficiency in SAS/Base, SAS/Stat and SAS/Macros.
  • Require Strong R proficiency.
  • CDISC proficiency required
  • SAS/GRAPH experience (Kaplan-Meier plots, swim lane plots) strongly preferred
  • Knowledge of appropriate regulations, industry standards and guidance documents
  • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways
  • Good interpersonal communication skills to collaborate effectively with internal cross-functional groups and external partners.
Benefits
  • Health insurance
  • Professional development opportunities

Applicant Tracking System Keywords

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

Hard skills
SASSAS/BaseSAS/StatSAS/MacrosSAS/GRAPHRCDISCstatistical programmingSDTMADaM
Soft skills
technical leadershipproblem-solvingcommunicationcollaborationoversightproject managementinterpersonal skillscreativitytime managementtroubleshooting