Principal Statistical Programmer

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 environment.
• 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.