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Principal Statistical Programmer (Oncology), Sponsor Dedicated

6+ years
$110,000 - $145,000 USD
10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: BE/BCS/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Principal Statistical Programmer (Oncology), Sponsor Dedicated
Location: Remote (US or Canada)
Category: Clinical
Job ID: 2442966


Job Overview

Fortrea is seeking a Principal Statistical Programmer with oncology experience to join our FSPx (sponsor-dedicated) model. This remote position offers the opportunity to lead programming activities on oncology clinical studies, working with SAS to create SDTM, ADaM datasets, and TFLs, and ensuring adherence to high-quality standards. You will be mentoring junior programmers and contributing to continuous process improvements, all while working in a high-energy, collaborative environment.

Key Responsibilities

  • Leadership:
    • Lead statistical programming on studies, including resource estimation, budgeting, timeline management, and collaboration with other departments and clients.
    • Mentor and train junior programmers.
    • Present and share knowledge at department meetings.
  • Programming & Data Management:
    • Develop and maintain SAS programs to create SDTM, ADaM datasets, TFLs, and quality check (QC) processes.
    • Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs, and Reviewer's Guides.
    • Lead and/or contribute to the development of complex specifications for SDTMs and ADaM datasets.
  • Quality & Compliance:
    • Ensure adherence to CDISC standards related to SDTM and ADaM, including define.xml and submission standards.
    • Respond to QA audits and client reviews.
    • Contribute to proposal activities and participate in bid defenses.
  • Continuous Improvement:
    • Identify and suggest ways to improve efficiency, quality, and productivity in statistical programming processes.

Qualifications

  • Education:
    • Bachelor’s degree in mathematics, statistics, computing, life science, health science, or related field.
    • Relevant work experience may be considered in lieu of educational requirements.
  • Experience:
    • 6+ years of SAS® programming experience in clinical research or the pharmaceutical industry.
    • 3-5 years of oncology-specific experience, including submissions experience.
    • Lead experience on complex studies and an understanding of clinical trials from start to finish.
    • Broad knowledge of CDISC requirements and submission standards for SDTM and ADaM.

Compensation & Benefits

  • US Pay Range: $110,000 - $145,000 USD
  • Benefits:
    • Comprehensive benefits including medical, dental, vision, life, STD/LTD, 401(K), ESPP, paid time off (PTO) or flexible time off (FTO), and company bonuses (where applicable).

Company Overview

Fortrea is a global leader in clinical research, transforming drug and device development through rigorous scientific solutions and innovative practices. We are committed to overcoming barriers in clinical trials and delivering life-changing therapies to patients in need.

Equal Opportunity Employer Statement

Fortrea is an Equal Opportunity Employer and promotes diversity and inclusion in the workforce. We make employment decisions based on qualifications and business needs while maintaining a harassment-free environment.

Accommodation

For reasonable accommodations during the hiring process, please contact taaccommodationsrequest@fortrea.com.