发帖
雷达卡
有兴趣者请联系 yujie.ma@excel-cro.com
Position Description
Performs biostatistical activities for given clinical trials involving drugs, biologics and medical devices, Assist to oversee the activities of biostatistician consultants and provides technical support to the team.
Responsibilities
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Participates in clinical development plan, study design and develops statistical section in clinical trial protocols
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Develops and evaluates statistical methodology
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Performs sample size and statistical power calculations
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Generates randomization schedule
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Develops statistical analysis plans including table shells design for individual studies and integrated summaries of safety and efficacy
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Reviews protocols, statistical analysis plans or other study documents developed by other biostatistician(s) or consultant(s) and provides guidance
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Supports data safety monitoring board (DSMB) or data monitoring committee (DMC) and clinical endpoints committee (CEC) regarding to statistics analysis
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Supports for regulatory submission (e.g. NDA and PMA) including writing statistical part for eCTD
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Represents biostatistician team at project team meetings and provides updates to project team on status of tasks
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Writes statistical report and participates in integrated clinical and statistical report writing
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Consults on other statistical tasks, such as support for CRF design, database development, data validation plan and blinded data review
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Consults on analysis strategies for interim analysis and integrated summaries of safety and efficacy (ISE/ISS)
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Performs SAS programming to generate tables, listings, figures, and statistical analyses
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Mentors and trains low level biostatisticians and new colleagues
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Provides technical support to the biostatistics team
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Performs other duties assigned by supervisor
Qualifications
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An advanced degree (Ph.D. or M.S.) in biostatistics, statistics or related field
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A minimum of 4 years (for M.S.) or 2 years (for Ph.D.) experience of biostatistics and/or statistical programming applied to drug or medical device development; being familiar with CDISC data standards is desired
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Strong writing skills required to be able to write sections of protocols, statistical reports, clinical study reports, and randomization plans
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Significant statistics experience in CRO or pharmaceutical R&D including all phases and large studies
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Experience of international drug development in a multicultural environment is a plus
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Ability to deal with sensitive inquiries or complaints from clients or potential clients and to protect confidentiality
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Be knowledgeable in all aspects of the drug agencies (e.g. FDA) regulations and requirements governing the conduct of drug and medical device studies including, but not limited to, GCP and ICH requirements
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Excellent communication and interpersonal skills, willingness and ability to encourage and support others to ensure the achievement of team goals.
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Be able to make effective presentations in public settings
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Proficient working in a PC/Windows environment
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A good command of English language if one’s native language is not English
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