Biostatistics Director

Role Summary

Provides leadership within biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases. Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements. Develops and/or applies statistical theories, methods and software. Partners in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data. Develops and implements biostatistics department policies, standards, practices and work-instructions in coordination with department leader and leaders in other functions. Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success. Represents biostatistics function in interactions with institutional review boards, ethics committees, and health agencies. 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

• Education/Experience/Knowledge & Skills: BS/BA in Statistics/Biostatistics or related discipline with a minimum of thirteen years of related experience; or MS/MA with a minimum of eleven years; or PhD with a minimum of eight years; or equivalent combination of education and experience. May require certification in assigned area.
• Experience/The Ideal For Successful Entry Into Job: Managed or supported clinical trials, preferably oncology in biotech/pharmaceutical industry; preferably led a phase III trial; 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 clinical trial requirements (oncology focus); developed/reviewed SDTM/ADaM specifications; excellent knowledge of FDA/EU statistical guidelines; experience with SAS, EAST, nQuery, Cytel Studio; ability to guide major programs and collaborate with data management, clinical operations, regulatory affairs and drug safety; strong project management and vendor negotiation skills; ability to develop technical/business solutions to complex problems; ability to interpret and modify company-wide policies and divisional programs; strong analytical and business communication skills.
• Job Complexity: Works on significant and unique issues; exercises independent judgment; participates in corporate development of methods and criteria; ensures budgets and schedules meet requirements; creates networks and frequently interacts with executives and major customers.

Skills

• Statistical design and analysis for clinical trials; regulatory guidance and compliance expertise.
• SDTM/ADaM specification development and review.
• FDA/EU statistical guidelines mastery.
• Statistical data management and analysis across Phase I–IV; NDA support.
• Proficiency with SAS, EAST, nQuery, Cytel Studio; data organization and advanced analyses.
• Strategic thinking, problem solving, and cross-functional collaboration.
• Vendor management and contract negotiation capabilities.
• Ability to influence policy and drive company objectives; strong communication skills.

Education

• BS/BA in Statistics/Biostatistics or related discipline with at least 13 years of related experience; or
• MS/MA in Statistics/Biostatistics or related discipline with at least 11 years of related experience; or
• PhD in Statistics/Biostatistics or related discipline with at least 8 years of related experience; or
• Equivalent combination of education and experience.
• May require certification in assigned area.