ClinChoice

Principal Statistical Programmer Consultant

ClinChoice

contract

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Lead

About the role

  • Participate in CRF design, database review, data management plan, data review, data validation procedures, and review of data listings
  • Produce data listings, summary tables, and graphics for interim and final analyses
  • Integrate data across studies within a project and validate analysis datasets
  • Test, document, review, and validate all programs according to department guidelines
  • Coordinate data transfer and programming standards with CROs and vendors and validate vendor-delivered TFLs and datasets
  • Collaborate with other Biometrics functions on clinical trial data analysis activities
  • Execute ad-hoc requests, manuscripts, posters, and presentations
  • Serve as client-facing principal statistical programming consultant working directly for a single sponsor while supported by ClinChoice

Requirements

  • Minimum of 10 years of SAS programming in the pharmaceutical or biotechnology industry with a BA/BS in computer science, statistics, math, or MA/MS with 8 years of experience
  • Expertise in SAS programming language, report generation, and standards for programming and validation
  • Therapeutic area - Rare Disease
  • Experience with CDISC data standards required
  • Experience as a senior statistical programmer at a pharmaceutical or CRO working in an FDA-regulated environment
  • Experience with Clinical Study Reports and NDA submission
  • Ability to work on multiple tasks simultaneously and meet project deadlines
  • Excellent verbal/written and interpersonal skills for cross-functional teamwork
  • Client-facing experience and ability to work independently while establishing a high-trust environment with client counterparts