Find & Apply For Biostatistics Manager / Director Jobs in Gaithersburg, Maryland

Director Biostatistics at Green Key Resources Director Biostatistics at Green Key Resources in Gaithersburg, Maryland Posted in about 12 hours ago.

Type:

full-time 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.