Statistical Programming
panacroDenver (CO)
About the role
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.
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