Director

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

Job summary

Green Key Resources is assisting a science-driven global biopharmaceutical company in seeking a Statistical Science Director to lead late-stage oncology and hematology programs across global clinical development. The role requires steering biometrics strategy, guiding cross-functional teams, and influencing governance and regulatory interactions.

You will shape statistical design, ensure excellence in study delivery, and provide strategic leadership across internal teams and external partners.

Qualifications

• MSc in Statistics, Mathematics (with substantial statistical coursework) or equivalent.
• PhD in Statistics is preferred.

Responsibilities

• Lead statistical strategy for product development plans, clinical studies, regulatory submissions, HTA, and commercial support.
• Own statistical content for study design, analysis plans, interpretation, and submission-ready deliverables.
• Quantify and communicate benefit–risk, value, and uncertainty of emerging product profiles.
• Provide global leadership and direct project work across internal teams and CRO partners.
• Represent the biometrics function in interactions with health authorities, advisory boards, payer groups, and scientific forums.
• Maintain expertise in statistical methodology and champion innovative approaches.
• Contribute to internal governance and decision-making committees.
• Mentor and support the development of junior statistical staff.

Skills

Statistical leadership

Cross-functional collaboration

Mentoring

Regulatory interactions

Education

MSc in Statistics/Mathematics

PhD in Statistics (preferred)

Job description

A science‑driven global biopharmaceutical company is seeking a Statistical Science Director to lead late‑stage oncology and hematology programs across global clinical development. This role is ideal for a seasoned statistician who can independently drive biometrics strategy, guide cross‑functional teams, and influence high‑level governance and regulatory interactions.

You’ll shape statistical design, ensure excellence in study delivery, and provide strategic leadership across internal teams and external partners. This position offers the opportunity to impact pivotal trials and contribute to the advancement of innovative therapies in oncology.

Key Responsibilities

• Lead statistical strategy for product development plans, clinical studies, regulatory submissions, HTA, and commercial support.
• Own statistical content for study design, analysis plans, interpretation, and submission‑ready deliverables.
• Quantify and communicate benefit–risk, value, and uncertainty of emerging product profiles.
• Provide global leadership and direct project work across internal teams and CRO partners.
• Represent the biometrics function in interactions with health authorities, advisory boards, payer groups, and scientific forums.
• Maintain expertise in statistical methodology and champion innovative approaches.
• Contribute to internal governance and decision‑making committees.
• Mentor and support the development of junior statistical staff.

Essential Qualifications

• MSc in Statistics, Mathematics (with substantial statistical coursework), or equivalent. PhD in Statistics is preferred.
• 7+ years of experience as a statistician in clinical trials, pharmaceutical development, regulated research, or related areas.
• Demonstrated ability to independently lead statistical strategy and cross‑functional collaboration.