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Senior Principal Statistical Programmer

1 month ago

Bengaluru, Karnataka, India inVentiv International Pharma Services Pvt. Ltd. Full time

Statistical Programming Experts at Syneos Health

Unlock Your Potential with Syneos Health

We are seeking experienced Statistical Programmers to join our dynamic team. If you're passionate about clinical research and data-driven healthcare advancements, this opportunity is for you

Open Positions :

- Senior Principal Statistical Programmer

- Principal Statistical Programmer

- Senior Statistical Programmer

Location : Remote (India)

Key Responsibilities :

Statistical Programming & Data Analysis :

- Develop and validate SDTM, ADaM datasets, and TFLs (Tables, Listings, and Figures) per regulatory and sponsor requirements.

- Perform complex statistical programming for clinical trials, ensuring compliance with CDISC standards.

Collaboration & Stakeholder Management :

- Work closely with biostatisticians, clinical teams, and data managers to deliver high-quality datasets.

- Communicate effectively with global teams, regulatory bodies, and sponsors.

Quality Control & Compliance :

- Ensure accuracy, consistency, and efficiency in programming outputs.

- Maintain adherence to GxP, FDA, EMA, and other regulatory guidelines.

Process Improvement & Innovation :

- Drive automation and process enhancements for efficiency and scalability.

- Contribute to best practices, SOP development, and knowledge sharing within the team.

Training & Mentorship :

- Provide technical leadership and mentorship to junior programmers.

- Conduct training sessions on programming best practices and new technologies.

Requirements :

- Minimum 8 years of experience in statistical programming

- Strong expertise in SDTM, ADaM, and TFL programming

- Experience with SAS programming in a clinical trial environment

- Familiarity with regulatory requirements (FDA, EMA, ICH-GCP)

- Excellent problem-solving and analytical skills

Why Join Syneos Health?

- Work on cutting-edge clinical research projects

- Be part of a growth-oriented and collaborative environment

- Make a real impact-your work will contribute to patient care and healthcare advancements

- Competitive salary and career growth opportunities

(ref:hirist.tech)