Lead Statistical Programmer Global Studies (Remote)
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Job Location:
Fairfield, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Description
Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates
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 ofprogramming 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
- 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
- Bachelors or Masters 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
Time Zone Requirements
- West Coast: 6-hour overlap with China; flexibility for late afternoon/evening PST collaboration
OR
- East Coast: 6-hour overlap with EU; flexibility for early morning EST collaboration (approx. 5:0011:00 AM EST)
Required Experience:
IC
About Company
Penfield Search Partners is a specialized property and casualty insurance, pharmaceuticals, biotech, and life sciences recruiting agency. Contact us!
