Principal Statistical Programmer
📍 Available in 3 Locations
Category: Clinical
🆔 Job ID: 25189
Job Overview
The Principal Statistical Programmer serves as the Lead Statistical Programmer, responsible for planning, executing, and overseeing all statistical programming activities on clinical studies. This includes resource planning, budget management, quality assurance, client interactions, and mentoring junior programmers.
The role ensures compliance with CDISC standards, generates SDTM/ADaM datasets, and supports all statistical deliverables throughout the study lifecycle.
Key Responsibilities
Study Programming & Oversight
Plan, execute, and manage programming activities for studies, ensuring timelines, budget adherence, and quality standards are met.
Develop and maintain SAS programs for creating SDTM and ADaM datasets and TFLs (Tables, Figures, Listings).
Perform QC of SDTM, ADaMs, and TFLs to ensure accuracy and compliance.
Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs, and Reviewers Guides to support SDTM and ADaM datasets.
Specifications & Standards
Develop or lead the development of complex specifications for SDTM and ADaM datasets.
Contribute to the establishment of Fortrea and client standards.
Review SAPs and TFL shells from a programming perspective and advise on complex TFL shell development.
Mentorship & Knowledge Sharing
Mentor junior programmers on SDTM, ADaM, and TFL processes, ensuring adherence to department practices.
Present and share knowledge during departmental meetings.
Quality & Compliance
Respond to QA audits, client audits, and support qualification audits.
Ensure deliverables comply with CDISC standards, including define.xml, Reviewer’s Guide, and submission standards.
Business Development & Process Improvement
Contribute to proposal activities and participate in bid defense meetings.
Identify and implement ways to improve efficiency, quality, and productivity in statistical programming.
Other Duties
Perform any other duties as required or assigned by management.
Qualifications
Education
Bachelor’s degree in Mathematics, Statistics, Computing, Life Sciences, Health Sciences, or related fields.
Equivalent experience may be considered in lieu of formal education.
Language Skills
English: Proficient in speaking, writing, and reading.
Experience
Minimum Required
Typically 6 years of SAS® programming experience in CRO or pharmaceutical industry, or equivalent.
Experience as Lead Statistical Programmer on complex clinical studies.
Broad understanding of clinical trial processes from study setup to completion.
Knowledge of roles and responsibilities across disciplines (e.g., Biostatistics, Clinical Data Management).
Strong expertise in CDISC SDTM and ADaM standards, including define.xml, Reviewer’s Guide, and submission requirements.
Work Environment & Travel
Office or home-based environment, as directed by management.
Travel required: Local, domestic, regional, or global.
Approx. 5% of time dedicated to travel
Overnight stays may be required (up to 100% of travel time)
Primarily for client meetings and trainings
Additional Information
Learn more about EEO & Accommodations request here.
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