Conducts statistical analysis and prepares statistical reports for pre-clinical and clinical studies in support of U.S. and international registration applications. Provides sample size calculation, protocol and CRF review, and statistical analysis plan development as needed. Participates in planning, writing, and review of abstracts, manuscripts, and meeting presentations.
- Performs statistical analysis for pre-clinical, clinical, and post-marketing projects in support of product development and U.S. and international product registrations.
- Responsible for statistical integrity and accuracy of clinical data prepared for regulatory filings.
- Provides statistical support consistent with prevailing standards for good statistical methodology, regulatory, and departmental guidelines and in compliance with associated ICH, US and EU regulations.
- Ph.D. degree in statistics, biostatistics, or closely related field.
- Minimum 4 years' experience in the pharmaceutical/biotechnology industry in support of clinical studies preferred.
- Good working knowledge of major statistical software packages (e.g., SAS, S-plus, R) is a plus.
- Excellent communication skills with the ability to interface at all levels, both within Cerus and with outside organizations.
- Ability to integrate statistical and biomedical concepts.
- Strong attention to detail and accuracy.
- Time management skills (timelines, schedules, task prioritization).
- Flexible; ability to adapt to changing priorities.