Principal Statistical Programmer

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 is pipelining talent for an evergreen Principal Statistical Programmer role in pharma. If you’re looking for a project-based career as a Principal Statistical Programmer, we’d love to have a preliminary conversation, connect with us to explore future opportunities!

This is a pipeline opportunity for proactive candidates interested in joining a global leader in the life sciences industry.

Job Description

The Principal Statistical Programmer provides technical leadership and expertise in the statistical programming activities for clinical trials and pharmacovigilance studies. This senior position takes charge of complex programming deliverables, ensures quality and regulatory compliance, mentors team members, and plays a key role in the development and review of data standards, analysis datasets, and study outputs.

Key Responsibilities

• Lead programming efforts for multiple studies, ensuring high-quality, timely deliverables.
• Develop, validate, and document complex SDTM and ADaM datasets, and TFL outputs according to CDISC and regulatory standards.
• Oversee and review programs, code, and documentation prepared by other programmers.
• Serve as a technical subject matter expert for programming standards, tools, and best practices.
• Collaborate with cross-functional teams including statisticians, clinical data management, medical writing, and regulatory affairs.
• Provide oversight and guidance to junior programmers, including mentoring and training.
• Participate in the design, implementation, and improvement of department processes and tools.
• Support regulatory submissions (e.g., FDA, EMA) with high-quality data and outputs.
• Resolve complex technical challenges and lead root cause analysis of programming issues.
• Contribute to the development and maintenance of global programming standards and SOPs.

Must Haves

• Bachelor’s or Master’s degree in Statistics, Mathematics, Life Sciences, Computer Science, or related field.
• 7+ years' experience in statistical programming within the pharmaceutical, biotechnology, or CRO industry.
• Advanced SAS programming skills (Base, Macro, SQL), with strong experience in SDTM and ADaM dataset creation and validation.
• In-depth knowledge of CDISC standards, FDA/EMA guidelines, and regulatory submission requirements.
• Demonstrated ability to lead programming teams or projects and manage timelines.
• Strong problem-solving, organizational, and communication skills.
• Proven ability to mentor, train, and provide technical guidance to programmers.
• Experience preparing datasets, outputs, and documentation for regulatory submissions.

Nice to Haves

• Experience with R, Python, or other statistical programming languages.
• Prior involvement in IND/NDA/BLA/MAA submissions.
• Familiarity with data visualization tools (e.g., Spotfire, Tableau) and automation technologies.
• Experience with cloud-based or modern data platforms.
• Contribution to industry working groups (e.g., CDISC, PHUSE).
• Participation in the development and rollout of global standards or new SOPs.