Biostatistics Director

Role Summary

Biostatistics Director provides leadership within the biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases. Applies statistical methodology to meet project objectives, regulatory requirements, and health authority guidelines. Develops and applies statistical theories, methods and software; partners in clinical development, study design, and data collection, management, and reporting. Develops biostatistics department policies and standards in coordination with department and other functions. Provides strategic statistical and regulatory guidance, represents biostatistics to IRBs/ethics committees and health agencies, and manages timelines, deliverables, and budgets of contract research organizations.

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

Experience

• Managed or supported clinical trials, preferably in oncology within the biotech/pharmaceutical industry.
• Led a phase III clinical trial (preferred).
• In-depth knowledge of CDISC standards.
• Management and statistical analysis of data from Phase I – IV 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 knowledge of statistical experimental designs, analyses and trial requirements, especially for oncology.
• Developed/reviewed SDTM/ADaM specifications.
• Excellent knowledge of FDA/EU statistical guidelines.
• Experience with data organization and statistical analyses using SAS, EAST, nQuery, Cytel Studio.
• Ability to guide major programs by selecting appropriate techniques and evaluation criteria.
• Understanding of data management, clinical operations, regulatory affairs, and drug safety.
• Project management and contract negotiation with outside vendors.
• Ability to develop technical and/or business solutions to complex problems.
• Interprets and revises company-wide policies or divisional programs as needed.
• Strong analytical and business communication skills.

Education

• As listed in Education/Experience section above.