Job 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.

Essential Duties And 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.

Supervisory Responsibilities

No supervisory responsibilities.

Education/Experience

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

• 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/The Ideal For Successful Entry Into Job

Managed and or supported clinical trials, preferably in the therapeutic area of oncology and in the biotech/pharmaceutical industry. Preferably led phase I and II clinical trials. In-depth knowledge of CDISC standards. 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.
• Must have experience in state-of-the-art data organization and statistical analyses using statistical software such as: R and SAS.

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