Senior Biostatistician

Location: Remote - candidates must be located in the United States

We are seeking a Principal Biostatistician to provide strategic and hands-on statistical leadership across discovery, preclinical, and clinical programs supporting RNA-based therapeutics. This role serves as a team lead and partners closely with cross-functional stakeholders to drive study design, data analysis, and regulatory-ready deliverables throughout the drug development lifecycle.

Key Responsibilities

• Lead statistical strategy, study design, and data analysis across discovery, preclinical, and clinical development for RNA-based therapeutic programs.
• Author and review statistical analysis plans (SAPs), study protocols, and related documentation in compliance with regulatory standards.
• Provide statistical leadership for dose-finding studies, PK/PD modeling, biomarker analyses, and translational research.
• Partner cross-functionally with Clinical Development, Biometrics, Bioinformatics, Regulatory, and Discovery teams to support program objectives.
• Oversee and critically review statistical deliverables from CROs and external vendors, ensuring quality, accuracy, and on-time execution.
• Apply and interpret advanced statistical methodologies for complex, high-dimensional, and longitudinal datasets.
• Support regulatory submissions, investigator brochures, clinical study reports, and scientific publications.
• Clearly communicate statistical concepts and results to both technical and non-technical stakeholders.
• Mentor junior statisticians and contribute to the development of biostatistics best practices.

Qualifications

• PhD or MS in Biostatistics, Statistics, Mathematics, or a related quantitative discipline.
• Minimum of 5 years of biostatistics experience within the pharmaceutical or biotechnology industry.
• Hands-on experience supporting RNA-based therapeutics (e.g., siRNA, mRNA, antisense oligonucleotides).
• Strong knowledge of drug development processes, including preclinical and clinical trial design.
• Proficiency with statistical programming and analysis tools such as SAS and R.
• Experience managing CROs and overseeing outsourced statistical activities.
• Working knowledge of regulatory guidelines and submission requirements (ICH, FDA, EMA).
• Excellent written and verbal communication, collaboration, and problem-solving skills.