Director Biostatistics

Director of Biostatistics

Directs departmental activities and maintains the statistical integrity of clinical trials. Leads efforts in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required.

Primary Responsibilities:

Manage statistical and statistical programming activities involved in the design, analysis and interpretation of clinical trials data conducted by .

Supervise and direct staff, both permanent and temporary, to include assignment of work, allocation of statistical resources and management of time lines to ensure contractual obligations and objectives are met.

Serve as a consultant with internal and external cross-functional areas regarding statistical operations

Function in the role as Senior Biostatistician on clinical trial(s) as required.

Assess operational needs and requirements; ensure efficient allocation of resources and adequate staffing to meet goals and objectives of the department.

Contribute to the development of standard operating procedures for clinical trials; ensure that statisticians and statistical programmers appropriately interpret and follow procedures.

Prepare reports that summarize the analysis of data, interpret findings and provide conclusions and recommendations.

Represent statistical operations department at regulatory meetings, sponsor meetings, and any other multifunctional meetings.

Adheres to all aspects of the quality system

Complies with data integrity & business ethics requirements

Perform other related duties incidental to the work described herein.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Skills:

Successful record of accomplishment in establishing, directing and overseeing statistical operations division/department

Working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11

Skilled in analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills

Excellent analytical skills, with the ability to process scientific and medical data

Excellent knowledge of statistical programming

Ability to identify data issues, present problems, and implement solutions

Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues

Good leadership, organizational and time management skills, with the ability to multi-task

Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)

Strong interpersonal communication and presentation skills

Education or Equivalent Experience:

Master degree in statistics, biostatistics or other related, scientific field and six years of relevant professional experience; or an equivalent combination of relevant education and/or experience

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