Senior Statistical Programmer (SDTM)
JobgetherRemotely
datasasich gcp21 cfr 11cdiscsdtmsas macrosrecistimwg
Job Description
📋 Description
- Lead SDTM programming on clinical studies, delivering SDTM deliverables.
- Program and deliver complex SDTM datasets per study requirements and standards.
- Develop and review SDTM Trial Design domains and mapping specs.
- Coordinate study start-up activities, defining programming deliverables.
- Review SAPs and protocols, advising on SDTM mapping strategies.
- Perform programming, QC, debugging SAS macros; support analysis and reporting.
🎯 Requirements
- Degree in a relevant discipline or equivalent experience.
- Experience in clinical trials or regulated environments.
- Strong SAS programming skills and SDTM/clinical reporting knowledge.
- SDTM Lead or study/ project lead experience on clinical projects.
- Proven SDTM/ CDISC standards knowledge, mapping, and regulatory submission experience.
- Experience mentoring and collaborating with cross-functional teams.
🎁 Benefits
- Full-time, remote working opportunity in India.
- Exposure to global clinical studies and diverse environments.
- Opportunities to enhance SAS, SDTM, CDISC, and clinical data programming expertise.
- Potential for technical leadership and study coordination roles.
- Mentoring, knowledge sharing, and professional development.
- Collaborative environment with global teams and process improvements.