Director of Biostatistics

A company is looking for a Director of Biostatistics.

Key Responsibilities

Lead biostatistics projects and ensure accountability for deliverables related to clinical development plans and study designs

Provide statistical input for regulatory submissions and respond to inquiries from regulatory agencies

Manage biostatistics vendors and oversee study biostatistician(s) and / or consultant(s)

Required Qualifications

PhD in biostatistics, statistics, or equivalent with at least 10 years of relevant experience (or MS with at least 13 years)

Extensive knowledge of GCP, ICH guidelines, and FDA regulations

Strong programming skills in SAS and understanding of CDISC SDTM and ADAM models

Ability to translate clinical study designs into statistical practice

Experience in managing multiple deliverables and short timelines