Sr. Biostatistician - Optimer Pharmaceuticals (San Diego, CA)

• Plan, coordinate, and conduct statistical activities related to assigned clinical projects, including trial design, statistical analysis, interpretation of results, and preparation of reports
• Provide power and sample size estimation, randomization, and protocol review
• Coordinate all statistical activities, review and finalize SAPs, review and finalize analysis datasets and specifications, and review and finalize clinical study reports
• Provide statistical input and direction to colleagues in other disciplines
• Provide guidance to CROs and review the corresponding deliverables
• Interact with CRO, clinical investigators, and other consultants to determine protocol design
• Evaluate databases and statistical analysis programs and interact with computer groups to determine hardware/software compatibility

Minimum of a Master's degree in Statistics and 4- 7 years experience working in Biostatistics and Clinical Research. Knowledge of FDA and ICH guidance documents is expected. Intermediate SAS skills (preferred), and NDA filling experience (preferred). Maintains expertise in state-of-the art data manipulation and statistical analyses.

Interested candidates fax or e-mail resume:
Attn: HR, 858-777-3468(fax) or careers@optimerpharma.com

Organization

Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products for the treatment of serious infections. Optimer has two late-stage anti-infective product candidates. OPT 80, currently in two pivotal Phase 3 clinical trials, is being developed for the treatment of Clostridium difficile-associated diarrhea, the most common hospital-acquired diarrhea. Prulifloxacin, also in two pivotal Phase 3 clinical trials, is an antibiotic being developed for the treatment of travelers diarrhea, a form of infectious diarrhea. Additional information regarding Optimer can be found at http://www.optimerpharma.com.

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