Job 08-010
Biostastician
Summary and Scope of Position:
Conducts statistical analysis and prepares statistical reports for pre-clinical and clinical studies in support of U.S. and international registration applications, including statistical analysis plans, sample size justification, protocol design, CRF review, analysis plan preparation, interpretation of study results, and preparation of clinical trial study reports. Participates in planning and writing of abstracts, manuscripts and presentations. Provides oversight and management assistance with contract statistical resources.
Primary Responsibilities:
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Plan, organize, supervise, and coordinate statistical activities for specific segments of clinical projects in support of product development and U.S. and international product registrations.
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Responsible for statistical integrity and accuracy of clinical studies.
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Interact with FDA or other regulatory agencies as appropriate in statistical aspects of study design, data analysis, and choice of statistical methodologies.
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Provides appropriate statistical advice and support to clinical researchers consistent with prevailing standards for good statistical methodology, regulatory, and departmental guidelines.
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Coordinate and provide quality oversight of contract research organization in activities related to data management and statistical analysis.
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Assist in training and support of clinical trial professionals from other functional areas in regards to basic statistical concepts necessary for the conduct of clinical trials.
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Participate in the development of process/manufacturing validation protocols with respect to sample size consideration and methods of proposed analysis.
Qualifications/Requirements/Skills:
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Ph.D. in Biostatistics or Statistics with a minimum of 4 years experience or a Master’s degree with a minimum of 6 years experience in the pharmaceutical/biotechnology industry in support of phase 1-3 clinical studies.
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Experience with major statistical software packages (including SAS).
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Excellent communication skills with the ability to interface at all levels, both within Cerus and with outside organizations.
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Ability to integrate statistical and biomedical concepts.
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Strong attention to detail and accuracy.
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Time management skills (timelines, schedules, task prioritization).
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Flexible; ability to adapt to changing priorities.
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