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- Health insurance
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Principal Statistical Programmer - Global Studies- REMOTE

Penfield Search Partners
Fairfield, CT

Quick Apply

Job Details

Contract

Qualifications

Data quality checks
Biostatistics
SAS
Data imputation
Data quality assurance
SAS language
ICH guidelines
Data quality monitoring
Clinical program data analysis
CDISC standards
Document quality checks
Clinical quality assurance standards
Clinical data analysis

Full Job Description

Contact: Neisha Camacho/Terra Parsons - [email protected]
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

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principal software engineer jobs in new haven, ct

Principal Statistical Programmer - Global Studies- REMOTE

Principal Software Engineer - Full Stack

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