This position is no longer open for applications

 Responsibilities include:

• Lead and perform biostatistics work in support of clinical development for one or more indication areas;
• Provide expertise with all statistical aspects of clinical study-related work (e.g., study design and protocol development, sample size and power calculations, writing statistical analysis plans, etc.);
• Work closely with the data manager, statistical programmer, project team members, outside business partners, external consultants, and CRO’s to insure the highest quality of data collections, analysis, and interpretation for all drug investigations;
• Maintain responsibility for statistical input to all major documents, including clinical development plans, protocols, clinical study reports, statistical reports, summaries of safety and efficacy and other sections of NDAs, and investigator brochure;
• Prepare draft reports, manuscripts, and graphical presentations to assist with the design and development of statistical analysis for clinical trails and for management presentation.

Qualifications and Other Required Knowledge and Skills:

A Ph.D. in Statistics/Biostatistics plus more than 3 years experience or an M.S. in Statistics/Biostatistics with greater than 6 years experience in the Pharmaceutical or Biotechnology industry.  Excellent understanding of theoretical and applied Statistics and extensive experience in clinical trials.  In-depth knowledge of FDA regulations, experience with FDA filings a plus.  Familiarity with ICH guidelines.  An in-depth knowledge of SAS.  Experience with other statistical software (e.g., StatXact, Nonlin, NQuery Advisor, NCSS/PASS, etc.) a plus.  Ability to work independently and experience with handling multiple tasks to meet deadlines in a collaborative drug development environment.  Effective at organization, presentation, documentation, management, communication and interpersonal skills with ability to lead and motivate scientific groups.