Biostatistics Director

Biostatistics Director

Requirements

• BS/BA degree in Statistics/Biostatistics or related discipline and a minimum of thirteen years of related experience; or,
• MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of eleven years of related experience; or,
• PhD in Statistics/Biostatistics or related discipline and a minimum of eight years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Responsibilities

• Work with department head to develop and implement department standards and practices.
• Direct the statistical design, conduct, and analysis of clinical trials in all phases.
• Review protocols and case report forms for soundness of trial design.
• Review and or author statistical analysis plans for all phases of a trial.
• Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
• Direct the development, validation and summary of integrated safety and efficacy summaries.
• Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements.
• Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development.
• Contribute to the development of Requests-for-Proposals.
• Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
• Responsible for all statistical oversight within a therapeutic area.

Preferred Qualifications

• Managed and or supported clinical trials, preferably in the therapeutic area of oncology and in the biotech/pharmaceutical industry.
• Preferably led a phase III clinical trial.
• In-depth knowledge of CDISC standards.
• Management and statistical analysis of data obtained from Phase I – IV clinical studies in support of US NDAs.
• Direct experience with FDA/EU Authority preferred.