Senior Statistical Programmer

Warman O'Brien; United States; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Warman O'Brien is seeking a Senior/Principal Statistical Programmer to lead high-impact projects in a small CRO setting. You will design and program SDTM/ADaM datasets, ensure data integrity, and collaborate with clients and regulatory agencies to support submissions.

You will mentor junior programmers, develop tools and macros to boost efficiency, and drive timelines while upholding rigorous statistical standards across multiple trials.

Qualifications

• Master’s or Ph.D. in Statistics, Biostatistics, Epidemiology, or Computer Science.
• 6+ years of clinical trial statistical programming experience with a Masters Degree or higher in a Statistical related subject.
• Experience working with clinical trial data, SDTM/ADaM datasets, and regulatory submissions.

Responsibilities

• Lead statistical programming for complex projects, solving intricate challenges while ensuring project 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, ensuring adherence to SOPs.
• Program and validate datasets, ensuring accuracy and data integrity.
• Mentor junior programmers and lead project teams, fostering development and collaboration.
• Innovate by developing macros, utilities, and tools to enhance efficiency.
• Implement data integrity checks, ensuring scientific accuracy and quality.

Skills

Statistical programming

SDTM/ADaM

Regulatory submissions

Leadership/mentoring

Education

Master's or Ph.D. in Statistics/ Biostatistics/ Epidemiology/ Computer Science

Job description

Senior/Principal Statistical Programmer | Small CRO | Remote/Hybrid

We're partnered with a small CRO who are experiencing a large amount of growth within Biometrics.

The Role:

As a Senior Statistical Programmer, you'll lead high-impact projects, tackling complex statistical programming tasks and managing project timelines. You'll work directly with clients and regulatory agencies, ensuring data quality and delivering programming solutions for clinical trials. You’ll also have the chance to mentor junior team members, contribute to regulatory submissions, and develop new programming tools.

Key Responsibilities:

• Lead statistical programming for complex projects, solving intricate challenges while ensuring project 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, ensuring adherence to SOPs.


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


• Mentor junior programmers and lead project teams, fostering development and collaboration.


• Innovate by developing macros, utilities, and tools to enhance efficiency.


• Implement data integrity checks, ensuring scientific accuracy and quality.

Qualifications:

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


• 6+ years of clinical trial statistical programming experience with a Masters Degree or higher in a Statistical related subject.


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