Statistical Science Director: Biostatistics Leader

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

Job summary

Green Key Resources seeks a Statistical Science Director to independently guide statistical strategies and activities across pharmaceutical programs. You will lead design, delivery, and interpretation for governance committees and regulatory submissions, and mentor staff while gaining external recognition as a methodology expert.

You will steer statistical thinking for development plans, regulatory strategy, HTA, and commercial presentations, partnering with experts to deliver high-quality

Qualifications

• Advanced degree in statistics/biostatistics or equivalent.
• Proven leadership in directing statistical strategy.
• Experience in clinical trials and regulatory submissions is essential.
• Strong communication and cross-functional collaboration skills.
• Mentors staff and drives technical excellence.

Responsibilities

• Lead statistical design and strategy for development plans and regulatory activities.
• Oversee statistical content for study designs, documents, and submissions.
• Quantify benefit, risk, value, and uncertainty of product profiles in governance settings.
• Provide global leadership and manage internal/external staff.
• Collaborate with CROs to ensure timely, high-quality delivery.
• Represent statistical strategy to external bodies and governance boards.
• Stay current with regulatory guidance and novel statistical methods.
• Mentor and train Statistics staff across projects.

Skills

Statistical leadership

Clinical trials

Regulatory submissions

Data analysis

Mentoring

Education

MSc/PhD in Statistics or related

Tools

SAS

R

Python

Job description

Green Key Resources seeks a Statistical Science Director to independently guide statistical strategies and activities across pharmaceutical programs. You will lead design, delivery, and interpretation for governance committees and regulatory submissions, and mentor staff while gaining external recognition as a methodology expert.

You will steer statistical thinking for development plans, regulatory strategy, HTA, and commercial presentations, partnering with experts to deliver high-quality