Associate Director, Biostatistics
$150,000–$170,000 year
HybridSomerset, New Jersey, United States
Job Summary
Develop and continuously improve SOPs, work instructions, templates, and processes to ensure compliance with ICH-GCP and regulatory requirements while driving operational efficiency. Oversee project execution by managing staffing, quality control, and issue resolution to deliver high-quality statistical services for Phase I–IV clinical studies. Provide expert statistical guidance on study design, protocol and CRF development, sample size calculations, and statistical analysis plans, serving as a trusted advisor to clients and cross-functional teams. Lead internal and external audits, ensuring timely resolution of findings and ongoing adherence to quality standards. Author and review statistical analysis plans and methodology sections for clinical protocols across multiple therapeutic areas. Collaborate with senior leadership on staffing, strategic planning, and business development activities.
Required Qualifications
- Master's degree or higher in Biostatistics, Statistics, Mathematics, or a related scientific field
- Bachelor's degree with equivalent experience
- 7+ years of experience in clinical trial biostatistics
- Expert knowledge of statistical methodologies and analyses
- Experience supporting clinical development programs
- Strong understanding of the drug development process
- Knowledge of applicable regulatory requirements, including NMPA, FDA, and ICH-GCP guidelines
- Proven leadership skills
- Experience in project planning and execution
- Experience in financial and risk management
- Experience in quality oversight
- Experience in team development
- Excellent communication skills
- Relationship-building skills
- Ability to collaborate effectively across cross-functional teams, clients, and stakeholders
- Highly organized
- Detail-oriented
- Quality-driven
- Strong track record of meeting timelines
- Track record of delivering reliable results
Desired Qualifications
- Master's degree or higher in Biostatistics, Statistics, Mathematics, or a related scientific field preferred
- Bachelor's degree with equivalent experience will also be considered
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