Job Summary

The Principal Statistical Programmer I provides leadership and advanced statistical programming support for complex clinical research projects. This role ensures the application of sound programming methodologies, delivers high-quality regulatory-compliant outputs, and serves as a subject matter expert across the organization.

Key Responsibilities

- Lead statistical programming activities for complex clinical research projects.
- Apply advanced SAS programming techniques to develop efficient and high-quality code.
- Provide expert statistical programming consultation across the company.
- Ensure compliance with regulatory standards by delivering accurate and reliable outputs.
- Develop and maintain well-organized programming documentation.
- Mentor and support junior statistical programmers to promote technical growth and best practices.
- Provide regular project status updates to management.
- Perform assigned programming tasks while adhering to project timelines and quality standards.
- Present statistical programming topics and best practices during internal knowledge-sharing sessions.

Required Skills and Expertise

- Advanced expertise in statistical programming, particularly using SAS.
- Strong understanding of regulatory requirements and industry standards for clinical research.
- Ability to design and implement efficient, high-quality programming solutions.
- Excellent documentation and organizational skills.
- Strong leadership, mentoring, and collaboration abilities.
- Effective written and verbal communication skills.

Preferred candidate profile

Preferred Candidate Profile

Key Responsibilities

- Lead statistical programming for complex clinical research studies.




- Develop advanced SAS programs (Base, Macros, SQL) and provide programming expertise.
- Ensure compliance with CDISC standards, ADaM/SDTM datasets, and TLF development.
- Deliver high-quality, regulatory-compliant outputs for clinical submissions and review meetings.
- Develop programming documentation, perform code reviews, validation, and support standardization initiatives.
- Write efficient, reproducible, and well-documented code.
- Mentor junior programmers and provide project updates to management.
- Present statistical programming topics internally and externally.

Education & Experience

- Bachelor's degree with 6+ years or Master's/PhD with 4+ years of statistical programming experience.
- Experience as a CDISC/TLF Statistical Programmer in a Pharmaceutical or CRO workplace.
- Scientific background preferred.

Required Skills

- Strong SAS programming (Base, Macros, SQL); knowledge of R/Python is an advantage.
- Expertise in CDISC standards (SDTM, ADaM) and TLF generation.
- Understanding of GCP, FDA, EMA, and ICH guidelines.
- Strong analytical, problem-solving, communication, and organizational skills.
- Ability to manage multiple priorities independently and collaborate effectively.

Core Competencies

- Collaboration and teamwork
- Initiative and accountability
- Results orientation
- Customer focus
- Strong ownership and continuous improvement mindset

Work Environment

- Standard office environment with low physical risk.
- Occasional travel between corporate locations may be required.

Additional Information

Responsibilities may evolve based on business needs, with reasonable accommodations provided where applicable.

📌 Principal Statistical Programmer (Karnataka)
🏢 Emmes
📍 Karnataka