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Principal Statistical Programmer

0-2 years
Not Disclosed
10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: 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
Location: Available in 3 locations
Category: Clinical
Job ID: 2444693


Job Overview

Fortrea is seeking a highly experienced Principal Statistical Programmer to perform the role of Lead Statistical Programmer. You will oversee all programming activities for studies, including resource estimation, budgeting, timeline management, quality maximization, and coordination with other departments and clients. The role requires you to develop and maintain SAS programs for SDTM and ADaM datasets and TFLs, as well as contribute to the development of Fortrea and client standards.

Key Responsibilities

  • Programming Leadership: Lead programming activities on clinical studies, including resource estimation, budgeting, and meeting project timelines.
  • Dataset Development: Develop and maintain SAS programs to create SDTM and ADaM datasets, TFLs, and perform quality control (QC) on datasets and outputs.
  • Documentation: Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs, and Reviewers Guides to support SDTMs and ADaMs.
  • Specification Development: Develop and lead the creation of complex specifications for SDTM and ADaM datasets.
  • Mentorship: Mentor junior programmers on SDTM, ADaM, and TFL processes and ensure adherence to best practices and department standards.
  • Client and QA Interaction: Respond to QA and client audits, support qualification audits, and assist with proposal activities.
  • Process Improvement: Continuously suggest ways to improve the efficiency, quality, and productivity of statistical programming.
  • Bid Defenses: Participate in bid defenses to secure new business opportunities.

Required Qualifications

  • Experience: Extensive experience in statistical programming, with a focus on SDTM, ADaM, and TFL creation.
  • Technical Skills: Strong expertise in SAS programming and the creation of datasets and analysis outputs.
  • Leadership: Proven ability to lead programming activities and mentor less-experienced programmers.
  • Communication: Strong ability to interact with clients and QA teams, and share knowledge effectively within the department.
  • Problem-Solving: Ability to identify areas for process improvement and suggest actionable solutions.

Company Overview

Fortrea is a leading global contract research organization (CRO) that provides clinical development, patient access, and technology solutions in over 20 therapeutic areas. With operations in approximately 100 countries, Fortrea is committed to transforming drug and device development, ensuring the rapid delivery of life-changing therapies to patients worldwide.

Equal Opportunity Employer Statement

Fortrea is an Equal Opportunity Employer that fosters diversity and inclusion. We are committed to providing a harassment-free and discrimination-free environment for all employees. Employment decisions are based on business needs and individual qualifications. All qualified applicants are encouraged to apply.

Accommodation

Fortrea provides reasonable accommodations for individuals who need assistance in the hiring process. Please reach out to taaccommodationsrequest@fortrea.com if you require accommodation during the application or interview process.