Clinical SAS Programmer Lead

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 simple 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.

(ref:hirist.tech)