Sign upLog in

Lead Statistical Programmer - Global Studies (Remote)

Penfield Search Partners

Fairfield, CT(remote)

Apply
JOB DETAILS
SKILLS
Analysis Skills, Biology, Biostatistics, Biotech and Pharmaceutical, Clinical Assessment, Clinical Data Interchange Standards Consortium (CDISC), Clinical Trial, Communication Skills, Computer Science, Continuous Improvement, Contract Research Organization (CRO), Data Sets, Delivery Management, Event Management, GCP (Good Clinical Practices), ICH Regulations, Mathematics, Performance Management, Process Improvement, R Programming Language, Regulatory Compliance, Statistical Analysis System (SAS), Statistical Programming Languages, Statistics, Team Player, Time Management
LOCATION
Fairfield, CT
POSTED
25 days ago
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 (EU and China exposure preferred)
  • 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
 
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
Additional Requirements 
  • Hands-on experience with LSAF - Life Sciences Analytical Framework
  • 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

About the Company

P

Penfield Search Partners

Resume Resources

Free Resume TemplatesFree Resume Builder