Lead Statistical Programmer Global Studies (Remote)

Fairfield, OH - USA

Monthly Salary: Not Disclosed

Posted on: 21 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description

Contact: Neisha Camacho/Terra Parsons -
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

East Coast: 6-hour overlap with EU; flexibility for early morning EST collaboration (approx. 5:0011:00 AM EST)

Required Experience:

Job DescriptionContact: Neisha Camacho/Terra Parsons -No 3rd party candidatesWe 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 deliverabl...

Job Description

Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates

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