Position Summary :

We are seeking an experienced Clinical SAS Programmer Lead to support Phase II-IV clinical studies and regulatory submissions. The ideal candidate will possess strong expertise in SAS programming, CDISC standards (SDTM/ADaM), TLF generation, and clinical trial data analysis.

This role involves leading programming activities, collaborating with cross-functional teams and clients, mentoring junior programmers, and ensuring high-quality regulatory deliverables within project timelines.

Key Responsibilities :

- Lead programming activities for Phase II-IV clinical studies of straightforward to moderate complexity.
- Develop, validate, and maintain SAS programs for data extraction, transformation, analysis, and reporting.
- Generate and validate Tables, Listings, and Figures (TLFs) for clinical and safety reporting.
- Create, validate, and deliver CDISC-compliant SDTM, ADaM, Define.xml, and aCRF deliverables.
- Analyze and integrate data from multiple sources, including clinical databases, virtual trials, and wearable devices.
- Support ISS, ISE, regulatory submissions, and responses to Regulatory Authority Questions (RTQs).
- Collaborate with project teams, biostatisticians, data management, and client stakeholders.
- Develop project timelines,



estimate resources, monitor budgets, and ensure timely delivery.
- Provide guidance and mentorship to junior programmers.
- Contribute to SOP development, training materials, process improvements, and departmental initiatives.
- Ensure compliance with CDISC standards and regulatory requirements across studies.
- Support statistical safety reporting, safety event notifications, and data alert generation.

Required Qualifications :

- Bachelor's or Master's degree in Computer Science, Statistics, Biostatistics, Mathematics, or a related field.
- 5+ years of clinical programming experience, preferably within a CRO environment.
- Strong hands-on expertise in SAS programming.
- End-to-end experience with CDISC SDTM, ADaM, and TLF development.
- Strong understanding of relational databases and clinical data structures.
- Experience supporting regulatory submissions, including ISS, ISE, and RTQs.
- Expertise in at least two therapeutic areas, including Oncology.
- Experience leading studies or programming teams.
- Familiarity with Agile methodologies and ways of working.
- Excellent communication and stakeholder management skills.
- Fluency in English.

📌 Clinical SAS Programmer Lead (India)
🏢 VUEVERSE CONSULTING SERVICES
📍 India