Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) is focused on becoming a global leader in the research, development and commercialization of novel antimicrobial drugs to combat serious and life-threatening bacterial and fungal infections. Cubist is evaluating the safety and efficacy of Cidecin® (daptomycin for injection) in the EDGE™ (Evaluation of Daptomycin against Gram-positive Entities) clinical trial program and has broadened its pipeline to include multiple pre-clinical drug candidates. The Company is engaged in strategic partnerships with Novartis Pharma AG for the discovery and development of novel antiinfectives and with Gilead Sciences for the commercialization of daptomycin in Europe. Cubist is headquartered in Lexington, MA and has operations in Vancouver, BC, Canada and Slough, UK.
The Director, Biostatistics will offer departmental leadership and management of providing statistical input into the design and development of project plans and regulatory strategies; in providing planning, delivery of statistical analyses, data presentations, and scientific reports for clinical trial results and for publication. While directing Clinical Biometrics colleagues in performing activities to provide the statistical expertise for the design and analysis of all clinical trials, the Director, Biostatistics will oversee and review the design and planning of appropriate statistical methodology in conformance with good statistical practices and with the FDA and ICH guidelines for all clinical development for worldwide filings. In addition, the chosen candidate will also; provide strategic biostatistical and scientific reporting expertise and contributions; participate with consultants in formulating strategies and standards; develop effective collaborations with internal and external regulatory, professional and academic organizations; and ensure that the Biometrics department meets time, quality and cost targets consistent with defined operating standards.
The ideal candidate will have a Ph.D. in Statistics or Biostatistics and 10 years of experience in the pharmaceutical industry, or relevant experience in clinical research. Project management and budget management expertise and experience in managing multiple, highly complex projects is required. Strong communications skills and the ability to work effectively in a global environment are expected. A record of scientific publications and/or presentations is desirable.
Cubist Pharmaceuticals, Inc.
65 Hayden Ave.
Lexington, MA 02421