Executive Director, Biostatistics

SUMMARY/

JOB PURPOSE:

Leads the biostatistics function in developing statistical strategy, design, and analyses for conducting clinical trials in all phases for multiple compounds. Understands at a deep level clinical trials principles and norms. 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.

Recruits, develops, and supervises project statisticians. Develops and implements biostatistics department policies, standards, practices, and work-instructions in coordination with senior department leader and leaders in other functions. Leads initiatives for process improvement and or standardizations for biostatistics activities and deliverables. Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success. Manages timelines, deliverables, and budgets of contract research organizations.

Essential Duties And Responsibilities:

Provide vision and direction for the development and implementation of department standards and practices.

Provide oversite of standardization and/or process improvement initiatives

Provide strategic input on Exelixis clinical development programs

Provide technical oversight of the statistical design, conduct, and analysis of clinical trials in all phases.

Review protocols and case report forms for soundness of trial design.

Review statistical analysis plans for all phases of a trial.

Direct analysis, interpret study results, and collaborate with study team to deliver interim reports, final reports, safety updates and publications.

Guide the successful completion of major programs, projects and/or functions by identifying and implementing appropriate techniques and evaluation criteria.

Lead or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.

Management and statistical analysis of data obtained from Phase I – IV clinical studies in support of NDAs.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 for evaluation of Contract Research Organizations for biostatistics, programming, and data management activities.

Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables, and budgets.

Responsible for all statistical oversight within the biostatistics function.

Interpret, execute, and recommend modifications to company wide policies and/or divisional programs. May establish organizational policies in a major segment of the company.

Build strong relationships both within and outside biostatistics

Supervisory Responsibilities:

Supervise biostatisticians.

Indirectly supervise employees in other functions through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE &

SKILLS:

Education/

Experience:

MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of 16 years of related experience; or,PhD in Statistics/Biostatistics or related discipline and a minimum of 15 years of related experience; or,Equivalent combination of education and relevant experience in oncology.

May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

Managed clinical trials in the therapeutic area of oncology for at least 5+ years and other therapeutic areas for 10+ years.

Supervision of multiple statisticians required.

Has led phase 1-4 (preferably phase
3) oncology studies.

Knowledgeable regarding FDA/EMA/ICH guidelines for drug development, new methodology in statistics and statistical/clinical data  knowledge of CDISC standards.

Ability to work simultaneously on multiple projects and multiple compounds, and to deliver high-quality work according to tight timelines.

Direct experience with FDA/EU Authority preferred.

Knowledge/

Skills:

Strong people management and interpersonal skills

Strong communication skills

Strong conflict management 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/ICH statistical guidelines.

Must have experience in state-of-the-art data organization and statistical analyses using statistical software such as SAS, EAST, nQuery, Cytel Studio.

Has understanding of other disciplines such as data management, clinical operation, clinical science, regulatory affairs, and drug safety.

Project management and contract…