Principal Statistical Programmer

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Statistical Programmer in REMOTE_LOCATION.

This role offers the opportunity to lead complex statistical programming projects in a dynamic clinical research environment. You will take ownership of high-impact projects, ensuring datasets, analyses, and regulatory deliverables meet the highest standards of quality and compliance. Acting as both a technical expert and mentor, you will guide junior programmers and biostatisticians while collaborating with cross-functional teams to support clinical trial submissions and scientific research initiatives. Your contributions will directly influence regulatory compliance, client satisfaction, and the advancement of innovative therapies. This position provides a mix of autonomy, leadership responsibility, and exposure to a variety of therapeutic areas and global regulatory standards, all within a flexible, remote-capable environment.

• Lead complex statistical programming projects, resolving technical challenges and ensuring high-quality, timely deliverables.
• Oversee development and validation of SDTM and ADaM datasets, define.xml files, and statistical outputs for CSRs, ISS, and ISE.
• Perform and review quality control (QC) checks, including CDISC-compliant validations and Pinnacle 21 error resolution.
• Provide mentorship, training, and technical guidance to junior statistical programmers and biostatisticians.
• Support regulatory submission activities, including preparation, review, and quality assessment of datasets and programming documentation.
• Develop and maintain programming utilities, macros, and internal best practices to enhance efficiency and consistency.
• Document and archive programming and clinical trial data in accordance with corporate SOPs and guidelines.
• Represent the team in client interactions, project proposals, and oversight discussions as required.

Requirements:

• Master’s or Ph.D. in Statistics, Biostatistics, Epidemiology, or Computer Science with 8+ years of clinical trial statistical programming experience, or a Bachelor’s degree with 10+ years of experience.
• Expertise in SDTM, ADaM, CDISC standards, and statistical programming validation processes.
• Strong proficiency with SAS or similar statistical programming tools and experience with regulatory submission datasets.
• Demonstrated ability to lead projects, manage complex datasets, and mentor junior team members.
• Knowledge of clinical trial design, statistical analysis plans, and regulatory requirements.
• Excellent problem-solving skills, attention to detail, and commitment to data quality and compliance.
• Effective communication and collaboration skills for working across cross-functional teams and global stakeholders.

Benefits:

• Competitive salary range of $125,000–$175,000 plus performance-based bonus opportunities.
• Flexible remote work options with home-based office setup.
• Comprehensive medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability.
• Pension plan, tuition reimbursement, and fitness reimbursement programs.
• Generous paid time off, sick leave, and employee assistance programs (EAP).
• Opportunities for professional growth and development in a leading clinical research environment.