Remote Senior SAS Programmer: CDISC SDTM/ADaM Expert

Planet Pharma; Warszawa; On-site; PLN 180,000 - 280,000; Full time

Job summary

Planet Pharma is seeking an experienced Senior Statistical Programmer to lead programming activities for clinical trials, ensuring high-quality deliverables for regulatory submissions. The role requires expertise in SAS, SDTM/ADaM, and Pinnacle 21 with a strong quality mindset.

You will mentor team members, collaborate across global project teams, and drive process improvements while adhering to SOPs and regulatory requirements.

Qualifications

• Master's or PhD in Statistics, Biostatistics, Epidemiology, Computer Science or related field with clinical trial programming experience.
• Strong knowledge of SAS programming within a clinical trials environment.
• Extensive experience with CDISC SDTM and ADaM standards and regulatory submissions.
• Experience with Pinnacle 21 validation.

Responsibilities

• Lead statistical programming activities across studies and projects.
• Drive resolution of programming issues with high-quality, timely deliverables.
• Program and validate SDTM and ADaM datasets for reports and regulatory submissions.
• Create and review define.xml documentation.
• Support and lead programming teams in regulatory submission activities.
• Perform QC and validation including Pinnacle 21 findings review.
• Develop programming utilities and macros to enhance efficiency.
• Ensure compliance with SOPs and study procedures.
• Maintain programming documentation and archival activities.
• Collaborate with cross-functional teams to deliver projects.

Skills

Problem-solving

Communication

Project management

Remote collaboration

Education

Advanced degree in statistics

Tools

SAS

Pinnacle 21

CDISC SDTM/ADaM

Job description

Planet Pharma is seeking an experienced Senior Statistical Programmer to lead programming activities for clinical trials, ensuring high-quality deliverables for regulatory submissions. The role requires expertise in SAS, SDTM/ADaM, and Pinnacle 21 with a strong quality mindset.

You will mentor team members, collaborate across global project teams, and drive process improvements while adhering to SOPs and regulatory requirements.