BioPhase · 1 week ago
Senior Biostatistician
United States
Full-time
Remote
Senior Level
$130K/yr - $170K/yr
5+ years expBioPhase is seeking a Senior 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.
BiotechnologyPharmaceuticalRecruitingStaffing Agency
Hiring Manager
Ashley Teixeira, MSc.
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
Qualification
Required
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
Company
BioPhase
BioPhase Solutions specializes in staffing and recruiting professionals for pharmaceutical, biotech and medical device companies.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase