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.
Statistical Programming in remote at Unknown Company
This position is listed as full time and onsite.