Senior Statistical Programmer Lead SDTM/ADaM & Submissions

Kelly Science, Engineering, Technology & Telecom; Poland; On-site; PLN 260,000 - 420,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom seeks a Principal Statistical Programmer to provide technical leadership in clinical trial programming and pharmacovigilance studies. You will lead complex SDTM/ADaM datasets and TFL outputs, ensuring regulatory compliance and high-quality deliverables.

The role includes mentoring junior programmers, collaborating with statisticians, data management, and regulatory affairs, and contributing to global programming standards and SOPs.

Qualifications

• Bachelor's or Master's in Statistics, Mathematics, Life Sciences, Computer Science, or a related field.
• 7+ years of statistical programming experience in pharma, biotech, or CRO.
• Advanced SAS programming skills with SDTM/ADaM experience.
• Strong knowledge of CDISC, FDA/EMA guidelines, and regulatory submissions.
• Ability to lead teams/projects and manage timelines.

Responsibilities

• Lead programming efforts for multiple studies with high quality and timely deliverables.
• Develop, validate, and document SDTM/ADaM datasets and TFL outputs per CDISC standards.
• Oversee programs and documentation prepared by other programmers.
• Act as a technical SME for programming standards, tools, and best practices.
• Collaborate with statisticians, data management, medical writing, and regulatory affairs.
• Mentor and train junior programmers; provide guidance on projects.
• Contribute to department process/tool improvements and SOPs.
• Support regulatory submissions with high-quality data and outputs.
• Lead root cause analysis of complex programming issues.

Skills

SAS programming

CDISC standards

Leadership

Regulatory submissions

Problem solving

Communication

Mentoring

Project management

Education

Bachelor's or Master's in Statistics

Tools

SAS Base

SAS Macro

SQL

Tableau

Job description

Kelly Science, Engineering, Technology & Telecom seeks a Principal Statistical Programmer to provide technical leadership in clinical trial programming and pharmacovigilance studies. You will lead complex SDTM/ADaM datasets and TFL outputs, ensuring regulatory compliance and high-quality deliverables.

The role includes mentoring junior programmers, collaborating with statisticians, data management, and regulatory affairs, and contributing to global programming standards and SOPs.