📍 Location: India-Asia Pacific - IND-Home-Based
📌 Job ID: 25002387
📅 Updated: March 20, 2025
Syneos Health® is a leading biopharmaceutical solutions organization dedicated to accelerating drug development and market success. With 29,000 employees across 110 countries, we provide innovative clinical and commercial solutions that bring life-changing therapies to patients faster.
As a Principal Statistical Programmer, you will be responsible for leading and managing statistical programming activities for multiple clinical studies. You will develop SAS programs to generate tables, listings, figures (TLFs), and datasets while ensuring compliance with CDISC, SDTM, and ADaM standards.
✔ Develop SAS programs to generate summary tables, listings, graphs, and derived datasets.
✔ Validate and ensure the quality of programming deliverables.
✔ Work with biostatisticians and project teams to resolve programming discrepancies.
✔ Ensure compliance with ICH guidelines, SOPs, and regulatory requirements.
✔ Serve as the lead statistical programmer for multiple global projects.
✔ Coordinate scheduling, time management, and programming activities across studies.
✔ Participate in project meetings, sponsor discussions, and bid defense meetings.
✔ Proactively communicate project status, risks, and mitigation plans to management.
✔ Develop and maintain study documentation, programming specifications, and validation plans.
✔ Ensure regulatory compliance by supporting CDISC submissions (SDTM, ADaM, DEFINE.XML).
✔ Conduct compliance reviews and contribute to standardization of programming processes.
✔ Act as a technical subject matter expert for CDISC standards and industry regulations.
✔ Provide training and mentorship to junior programmers and cross-functional teams.
✔ Contribute to SOP development and process improvements.
✔ Develop and optimize SAS macros and programming tools for efficiency.
🎓 Education:
🔹 Bachelor’s degree (preferably in Statistics, Computer Science, Mathematics, or a related field).
🔹 In lieu of a degree, equivalent experience in statistical programming will be considered.
💡 Experience & Technical Skills:
✔ Extensive SAS programming experience in a clinical trial environment.
✔ Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements.
✔ Prior experience in regulatory submissions and compliance is preferred.
✔ Strong understanding of clinical drug development and statistical principles.
✔ Ability to manage multiple projects and deadlines in a fast-paced environment.
🗣 Soft Skills:
✔ Excellent written and verbal communication skills.
✔ Strong problem-solving and leadership abilities.
✔ Ability to work in a collaborative, cross-functional team.
🔹 Work on 94% of FDA-approved drugs in the past five years.
🔹 Career growth with technical training, mentorship, and leadership opportunities.
🔹 Collaborative and innovative Total Self culture that values diversity and inclusion.
💼 Apply Today!
Join Syneos Health and contribute to life-changing innovations in clinical research.
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