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Principal Statistical Programmer - Global Studies- REMOTE

Fairfield, CT

Posted: 06/12/2026 Industry: Biotech/Pharmaceutical Job Number: 6174

Job Description

Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com
No 3rd party candidates

We are seeking a highly experienced Statistical Programmer to lead programming activities across global clinical studies. This role operates beyond executional programming, with responsibility for oversight of CRO deliverables, validation of outputs, and end-to-end accountability for statistical programming packages.

Key Responsibilities

  • Lead statistical programming activities across global studies
  • Serve as primary programming lead in collaboration with Biostatistics
  • Develop, review, and validate SDTM and ADaM datasets in accordance with CDISC standards
  • Review specifications and proactively challenge inconsistencies in protocols, SAPs, and dataset definitions
  • Validate program outputs and ensure accuracy, quality, and regulatory compliance
  • Provide oversight and guidance to CRO partners, consolidating and communicating feedback effectively
  • Manage timelines, delivery packages, and milestone commitments
    Contribute to continuous improvement of programming processes and standards

Core Requirements

  • Strong expertise in CDISC standards, including ADaM and SDTM
  • Demonstrated experience reviewing specs and ensuring high-quality, submission-ready deliverables
  • Working experience in LSAF environment
  • Experience validating CRO programming deliverables
  • Ability to operate with increased performance accountability and ownership
  • Strong CRO-facing communication and collaboration skills
  • Proven ability to manage multiple global studies simultaneously

Additional Requirements 

  • Practical experience with multiple imputation (MI), particularly under Missing at Random (MAR) assumptions
  • Familiarity with the estimands framework (ICH E9 R1) and managing intercurrent events (ICEs) within ADaM domains using various strategies

Qualifications

  • Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or related field
  • 5+ years of SAS programming experience within pharmaceutical/biotech
  • Strong understanding of statistical methods used in clinical trial analysis
  • Knowledge of Good Programming Practices and GCP
  • Preferred: Experience with R programming

Meet Your Recruiter

Terra Parsons
Director, Biometrics Recruitment

Terra is a Senior Recruiter with 20+ years of experience in the pharmaceutical industry. She is driven by a passion for comprehensively understanding the needs of both clients and candidates, and adeptly matching them with opportunities that align with their needs and interests. Her specialization lies in biometrics recruitment, with a focus on sourcing top talent in roles such as statisticians, SAS/statistical programmers, and data managers. Her track record speaks volume about her ability to deliver high-quality candidates and exceed client expectations. In her free time, she enjoys spending time with her family, traveling, and fitness. 

 
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About Fairfield, CT

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