Statistical Programming

About the Role:

We are seeking multiple Statistical Programming to join our team supporting clinical trial activities for a global pharmaceutical client. The successful candidate will lead and execute statistical programming deliverables for study conduct and regulatory submissions in compliance with CDISC and regulatory guidelines.

Key Responsibilities:

• Serve as the statistical programmer across multiple clinical studies.
• Develop and validate SAS programs for SDTM and ADaM datasets according to CDISC standards.
• Generate tables, listings, and figures (TLFs) for clinical study reports and regulatory filings.
• Contribute to data package readiness and submission support, including define.xml and reviewer guides.
• Maintain and enhance macro libraries and utilities to support efficient and consistent programming.
• Collaborate closely with biostatisticians, and data managers to ensure high-quality deliverables.
• Ensure compliance with SOPs, data standards, and regulatory requirements.

Minimum Qualifications:

• Bachelor’s or Master’s degree in statistics, computer science, life sciences, or a related field.
• Minimum 2-10 years of statistical programming experience in the pharmaceutical, biotech, or CRO industry.
• Expert-level proficiency in SAS, including macro development and debugging.
• Strong experience with SDTM and ADaM dataset creation and validation.
• Demonstrated experience in generating clinical TLFs and supporting submission deliverables.
• Excellent communication, organizational, and problem-solving skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications:

• Prior experience with regulatory submissions (e.g., eCTD).
• Familiarity with Pinnacle 21, define.xml, and related tools.