Director Biostatistics

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

Benefits offered by this job

Relocation package

Job summary

Green Key Resources is seeking a Statistical Science Director for Late Oncology/Hematology to lead statistical strategy across product development and clinical programs. The role is based in or commutable to Gaithersburg, MD, with a full relo package and relocation assistance provided.

The candidate will shape study designs, drive analyses, and oversee regulatory submissions, while partnering with CROs and internal statisticians to deliver high-impact insights for oncology and hematology

Qualifications

• MSc or PhD in Statistics, Mathematics, or a closely related discipline.
• 7+ years of statistical experience in clinical trials, with at least 5 years in Oncology or Hematology.

Responsibilities

• Lead statistical design and strategy across clinical development programs.
• Provide statistical leadership for study designs, analyses, interpretation, and regulatory submissions.
• Quantify and communicate benefit, risk, value, and uncertainty around emerging product profiles.
• Represent Statistics in senior internal governance and decision-making forums.
• Partner with CROs and oversee work performed by internal and external statistical resources.
• Represent the organization externally with health authorities, advisory boards, conferences, workshops, and/or payer interactions.

Skills

Statistical leadership

Study design

Regulatory submissions

Leadership

CRO management

Education

MSc/PhD in Statistics

Mathematics

Job description

The Statistical Science Director - Late Oncology/Hematology - is a highly visible statistical leadership position supporting product development and clinical programs, with responsibility for driving statistical strategy across study design, development planning, regulatory strategy, submissions, and interpretation of clinical data. This person would need to be based in or commutable to Gaithersburg, MD. The client would provide a full relo package and offer a service to help with relocation as well.

Key responsibilities include:

• Leading statistical design and strategy across clinical development programs
• Providing statistical leadership for study designs, documentation, analyses, interpretation, and regulatory submissions
• Quantifying and communicating benefit, risk, value, and uncertainty around emerging product profiles
• Representing Statistics in senior internal governance and decision-making forums
• Partnering with CROs and overseeing work performed by internal and external statistical resources
• Representing the organization externally with health authorities, advisory boards, conferences, workshops, and/or payer interactions

The team is looking for someone with an MSc or PhD in Statistics, Mathematics, or a closely related discipline and 7+ years of statistical experience within clinical trials, with at least 5 years in Oncology or Hematology. Strong technical expertise and a demonstrated ability to independently lead statistical strategy and project work are particularly important.