Biostatistics Director

Role Summary

Biostatistics Director

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.

Qualifications

• 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.

Experience

• 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 ‚Äì IV clinical studies in support of US NDAs.
• Direct experience with FDA/EU Authority preferred.
• Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training.

Knowledge/Skills

• Comprehensive and detailed knowledge of: statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to oncology trials.
• Developed/reviewed SDTM/ADaM specifications.
• Excellent knowledge of FDA/EU statistical guidelines.
• Management and statistical analysis of data obtained from Phase I ‚Äì IV studies in support of NDAs.
• Must have experience in state-of-the-art data organization and statistical analyses using statistical software such as: SAS, EAST, nQuery, Cytel Studio.
• Guides the successful completion of major programs, projects and/or functions by identifying and implementing appropriate techniques and evaluation criteria.
• Has understanding of other disciplines such as data management, clinical operation, clinical science, regulatory affairs and drug safety.
• Project management and contract negotiation with outside vendors.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve these goals in creative and effective ways.
• Develops technical and/or business solutions to complex problems.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
• Applies strong analytical and business communication skills.

Job Complexity

• Works on significant and unique issues where analysis scenarios require an evaluation of intangibles.
• Works on complex issues where analysis scenarios require an in-depth knowledge of the company.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
• Ensures budgets and schedules meet corporate requirements.
• Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.