Principal Statistician

Principal Statistician

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Statistician based in United States.

The role offers the opportunity to provide advanced statistical expertise and scientific leadership within a collaborative biometrics and data science environment. You will support complex clinical research projects across multiple therapeutic areas, helping transform data into meaningful insights that accelerate medical innovation. This position requires a strong combination of technical expertise, strategic thinking, and effective communication skills. You will contribute to study design, statistical analysis, regulatory-quality deliverables, and best practices across clinical development programs. Working alongside experienced professionals, you will help shape solutions, mentor colleagues, and drive excellence in statistical methodologies. This fully remote role is ideal for a proactive statistician who enjoys autonomy, collaboration, and impactful scientific work.

Accountabilities:

The Principal Statistician will provide statistical leadership across clinical research projects, ensuring high-quality methodologies, analyses, and deliverables while collaborating with cross-functional teams. Key responsibilities include:

• Provide statistical expertise and scientific guidance across internal projects and client-supported studies spanning different therapeutic areas.
• Lead statistical analysis planning, methodology development, and interpretation of complex clinical data.
• Support innovative study designs, advanced statistical modeling, simulations, and analytical approaches when required.
• Author, review, and provide input on Statistical Analysis Plans (SAPs), tables, listings, and figures (TLFs).
• Review and validate statistical outputs, including ADaM datasets and TLFs for Data Monitoring Committees, interim analyses, and clinical study reports.
• Contribute to regulatory submission activities and ensure statistical deliverables meet quality and compliance standards.
• Promote best practices in statistical programming, governance, and data-driven decision-making.
• Mentor and support team members by sharing expertise and encouraging professional development.
• Build strong relationships with internal stakeholders, clients, and cross-functional partners through clear communication and collaboration.

Requirements:

The ideal candidate will bring extensive statistical expertise within clinical research, along with strong communication and leadership capabilities. Required qualifications and skills include:

• Advanced degree (MSc or PhD) in Biostatistics, Statistics, or a related quantitative discipline.
• 7+ years of experience working as a Statistician within a CRO, pharmaceutical, biotechnology, or related clinical research environment.
• 7+ years of experience with CDISC standards.
• Strong knowledge of statistical methodology, including analysis of binary and continuous endpoints, missing data approaches, and clinical trial data interpretation.
• Experience developing or reviewing SAPs, TLF shells, and statistical documentation.
• Experience reviewing and validating ADaM datasets and statistical outputs.
• Familiarity with regulatory submissions and clinical development processes is preferred.
• Experience with advanced statistical techniques such as Bayesian methods, novel study designs, simulations, or complex modeling is advantageous.
• Strong programming skills in SAS; experience with R is a plus.
• Ability to work independently while contributing effectively within a collaborative team environment.
• Excellent communication, relationship-building, and problem-solving skills.
• Candidates must be located in one of the following states: Texas, North Carolina, Pennsylvania, New York, or Massachusetts.

Benefits:

• Fully remote work environment with flexible working hours.
• Opportunity to contribute to meaningful clinical research programs that support the development of new therapies.
• Career development opportunities, mentorship, and continuous learning support.
• Collaborative and supportive culture focused on technical excellence and innovation.
• Competitive compensation package.
• Opportunity to work with multidisciplinary teams across global clinical development projects.