• Provides biostatistics consulting in the design of protocols, drug development plans, and in the analysis and reporting of clinical trial data for all phases of drug development research. • Assists in the development of policies, procedures and standards for biostatistics activities. Supports the development and implementation of standard operating procedures and training program for staff. • Participates in the sales and marketing function as it relates to operational activities. Provides input and review/approval of study proposals upon request. • Interacts with senior management of pharmaceutical and biotechnology sponsors on operational issues. • Develops articles and presentations to be published in statistical journals and industry publications to promote the processes and technologies deployed by the biostatistics department. • Ensures compliance with Good Clinical Practices, sponsor contracts as well as all Food and Drug Administration, and International Conference on Harmonization requirements. • Maintains activity and visibility level providing representation for Company at professional meetings, including presentations at industry meetings, and other meetings relating to ICH issues or worldwide trends in biostatistics. • Acts as mentor and technical expert to junior biostatisticians and programming staff. Provides leadership, quality review, and mentoring to less experienced biostatisticians and coordinates the work of other biostatisticians. • Requires a Ph.D. in Biostatistics, or in science with statistics minor or equivalent, plus moderate design and analysis of clinical trials experience in a Contract Research Organization or Pharmaceutical/ Biotechnology company OR an MS degree plus more experience, or equivalent in education and experience. • A nominal amount of supervisory experience preferred. • Requires in-depth knowledge and application of FDA/ICH regulations and experience in interacting with the FDA. • Expert knowledge of major statistical software program, e.g. SAS is necessary. • Strong working knowledge of other software such as StatXact, Nonlin and EaSt is preferred. • Experience preparing and submitting regulatory documents is required. • Data management experience is preferred. • Highly effective presentation, documentation, negotiation, interpersonal and leadership skills with a team-oriented approach are necessary. • Strong computer skills in Microsoft Office Suite are necessary. • The ability to prioritize and handle multiple tasks in a dynamic environment is essential.