Statistical Science Director, Infectious Disease (Hybrid)

Green Key Resources; Durham (NC); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Green Key Resources seeks a Statistical Science Director – Infectious Disease to lead biostatistical strategy across clinical development programs, with emphasis on infectious diseases. Hybrid work model, 3 days onsite, Durham, NC or Gaithersburg, MD.

Responsibilities include trial design, statistical analysis, regulatory strategy, and cross-functional leadership. Mentoring statisticians and guiding CRO partners are key.

Qualifications

• Master's degree or PhD in Statistics, Biostatistics, Mathematics, or closely related field.
• Minimum 5 years of clinical trial experience within the pharmaceutical/biotech industry.
• Demonstrated experience independently leading statistical strategy for clinical development programs.
• Strong understanding of clinical trial design, statistical methodologies, and regulatory requirements.
• Experience overseeing statistical activities across multiple clinical studies.
• Strong communication, stakeholder management, and cross-functional leadership skills.

Responsibilities

• Lead statistical strategy, clinical trial design, and analysis across drug development programs.
• Provide statistical leadership for regulatory submissions, development plans, and health authority interactions.
• Oversee statistical deliverables across multiple studies, ensuring quality and regulatory compliance.
• Partner with clinical development, regulatory affairs, and other cross-functional teams.
• Apply advanced statistical methodologies, including simulation-based approaches and innovative trial designs.
• Guide internal statisticians and external CRO partners to ensure timely, high-quality deliverables.
• Present statistical recommendations to senior leadership and governance committees.
• Mentor and provide technical guidance to statistical team members.

Job description

Green Key Resources seeks a Statistical Science Director – Infectious Disease to lead biostatistical strategy across clinical development programs, with emphasis on infectious diseases. Hybrid work model, 3 days onsite, Durham, NC or Gaithersburg, MD.

Responsibilities include trial design, statistical analysis, regulatory strategy, and cross-functional leadership. Mentoring statisticians and guiding CRO partners are key.