Senior Statistical Programmer

Description:

Warman O'Brien is seeking a Senior Statistical Programmer to join a small but rapidly growing Clinical Research Organization (CRO) specializing in Biometrics. The role involves leading high-impact projects, managing complex statistical programming tasks, and ensuring timely and high-quality project delivery. You will work closely with clients and regulatory agencies, maintaining data quality and delivering programming solutions for clinical trials.

The position provides opportunities to mentor junior team members, contribute to regulatory submissions, and develop innovative programming tools. You will create and validate SDTM and ADaM dataset specifications, program and validate datasets, and implement data integrity checks to ensure scientific accuracy and quality. Additionally, you will have the chance to innovate by developing macros, utilities, and tools to enhance programming efficiency.

Key Responsibilities:

• Lead statistical programming for complex projects, ensuring delivery meets quality standards.

• Collaborate with clients, providing programming oversight, project estimates, and participating in bid defenses.

• Contribute to regulatory submissions and represent the company in regulatory discussions.

• Create and validate SDTM and ADaM dataset specifications following SOPs.

• Program and validate datasets, ensuring accuracy and data integrity.

• Mentor junior programmers and lead project teams.

• Develop macros, utilities, and tools to improve efficiency.

• Implement data integrity checks to ensure scientific accuracy and quality.

Qualifications & Requirements:

• Master’s or Ph.D. in Statistics, Biostatistics, Epidemiology, or Mathematics.

• 6+ years of clinical trial statistical programming experience with a relevant advanced degree.

• Experience with clinical trial data, SDTM/ADaM datasets, and regulatory submissions.