Statistical Science Director

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

Statistical Science Director – Infectious Disease

Location: Durham, NC or Gaithersburg, MD (Hybrid, 3 days onsite)

Position Overview

We are seeking an experienced Statistical Science Director to lead biostatistical strategy across clinical development programs, with a focus on infectious diseases. This is a highly visible leadership opportunity responsible for clinical trial design, statistical analysis, regulatory strategy, and cross-functional collaboration.

The ideal candidate will have strong pharmaceutical industry experience, demonstrated leadership across multiple clinical studies, and the ability to independently guide statistical decisions. Experience in vaccines or immunotherapy is preferred but candidates from other therapeutic areas will be considered.

Key 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.

Required Qualifications

• Master's degree or PhD in Statistics, Biostatistics, Mathematics, or a closely related field.


• Minimum 5 years of clinical trial experience within the pharmaceutical or biotechnology industry.


• Demonstrated experience independently leading statistical strategy for clinical development programs.


• Strong understanding of clinical trial design, statistical methodology, and regulatory requirements.


• Experience overseeing statistical activities across multiple clinical studies.


• Strong communication, stakeholder management, and cross-functional leadership skills.

Preferred Qualifications

• Experience in infectious diseases, vaccines, or immunotherapy, although other therapeutic areas are welcome.


• Experience supporting regulatory submissions and health authority interactions.


• Expertise in simulation methods, sample size determination, or interim analyses.


• Programming experience with SAS, R, or Python.


• Experience mentoring statisticians or leading statistical teams.


• Publications, external scientific collaborations, or recognition as a statistical methodology expert.


• Hybrid schedule with a minimum of 3 days per week onsite.


• Location flexibility between Durham, NC and Gaithersburg, MD.


• Competitive base salary with flexibility for highly qualified candidates.


• Opportunity to influence clinical development strategy and contribute to innovative therapies.