Principal Biostatistician – Inhouse Project

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and deliver statistical support for clinical studies, primarily within the field of Immunology or other therapeutic areas.

• Serve as the lead statistician for assigned studies, managing statistical strategy and deliverables.

• Author and review Statistical Analysis Plans (SAPs), Analysis Database Specifications (ADS), and the statistical sections of clinical study reports.

• Review and interpret analysis outputs, ensuring they meet accuracy, quality, and regulatory compliance standards.

• Collaborate with Clinical, Programming, Data Management, and Regulatory teams.

• Provide guidance and oversight to statistical programmers as required.

• Communicate statistical concepts, results, and risks to both technical and non-technical stakeholders.

• Ensure compliance with FDA, ICH, GCP, and company SOPs.

⛳️ Requirements

• MS or PhD in Statistics, Biostatistics, or a related discipline.

• Extensive experience in Oncology studies.

• Practical experience in writing Statistical Analysis Plans (SAPs).

• Practical experience in writing Analysis Database Specifications.

• Experience in reviewing and interpreting analysis results.

• Proficient in SAS programming (hands-on or with a strong working knowledge).

• Exceptional written and verbal communication skills.

• Experience in a CRO and/or pharmaceutical/biotech environment.

• Experience leading Phase II–III clinical trials is preferred.

• Prior interactions with regulatory agencies are preferred.

• Experience in mentoring junior statisticians or programmers is preferred.

🏝️ Benefits

• Opportunities for professional growth.

• A fulfilling and rewarding career.

• Continuous training and development.

• A culture of equal opportunity, diversity, and inclusivity.