Senior Clinical Statistical Programmer (US/Canada)

Senior Clinical Statistical Programmer

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you!

About the Role

Celerion is seeking a Senior Clinical Statistical Programmer to provide statistical programming support for early-phase clinical research. In this role, you will independently design, develop, validate, and maintain SAS programs to support the analysis and reporting of clinical trial data, lead statistical programming activities for assigned studies, and perform rigorous peer review and quality control of programming deliverables to ensure accuracy, consistency, and regulatory compliance.

This is not a general data analyst or data science position. Candidates must have prior hands-on experience in clinical trial statistical programming within a CRO or pharmaceutical clinical trials environment.

The Primary Responsibilities of this Position Are:

• Independently develop, maintain, and process SAS programs for clinical studies, creating analysis data packages (ADaM), statistical analyses, data listings, tables, and figures,

• Perform peer QC, double programming and validation functions for statistical outputs from studies.

• Lead statistical programming activities on studies and deliverables.

• Assist Management and Biostatisticians with complex projects.

• Design and implement SAS programs for standardized use.

• Train and mentor junior programmers.

• Ensure compliance with study protocol and departmental procedures.

Requirements

• Minimum of a Bachelor’s Degree in Statistics, Mathematical Science, Physics, or Computing related field.
• Minimum 3 years of hands-on statistical programming experience in a CRO or pharmaceutical clinical trials environment.
• Proficient in Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/ODS.
• Experience applying CDISC requirements to generate ADaM datasets and supporting documentation (define.xml, Reviewer’s Guides), demonstrating proficiency in these areas.
• Familiarity with Pinnacle 21 validation.
• Experience in early-phase clinical trials.
• Experience with Phase I Safety, PK/PD analysis programming.
• Excellent interpersonal skills.
• Strong problem-solving and decision-making abilities.
• Demonstrates a high level of attention to detail.
• Demonstrated ability to work collaboratively as part of a team.
• Familiarity with R, Python, and other programming languages is preferred.

Celerion is an equal opportunity employer.