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 Biostatistician/Senior Scientific Programmer |
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MacroStat(China)
头衔: 海归中士
性别: 
加入时间: 2011/10/10
文章: 2
海归分: 662
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作者：MacroStat(China) 在 生化制药 发贴, 来自【海归网】 http://www.haiguinet.com
MacroStat (China) Clinical Research Co., Ltd. is a CRO (Contract Research Organization) providing biostatistics and data management services to clinical as well as non-clinical studies in United States (US), Australia, Asia Pacific Region, Japan, United Kingdom (UK), China, and other countries. MacroStat is the unique CRO in China that has been doing projects for submitting to US FDA, CVM (Center for Veterinary Medicine) and EPA (Environment Protection Agency).
Senior Biostatistician or Biostatistician
Responsibilities include:
. Apply statistical theory and methods to the design and analysis for clinical trials in a variety of therapeutic areas.
. Prepare data analysis plans and write reports describing results of statistical analysis.
. Maintain expertise in new statistical methodologies and applications in pharmaceutical research.
. Prepare responses to regulatory agency questions regarding statistical aspects of clinical trials.
. Represent the Biostatistics Group in project team meetings and in interaction with regulatory agencies.
. Consult with research scientists, medical directors, and clinical managers on statistical questions.
Qualification:
. A degree in biostatistics or statistics, MS or PhD with a strong theoretical background in statistics is required.
. Knowledge of SAS programming for statistical analysis and data manipulation is essential. Knowledge of other statistical analysis software is desirable.
. The candidate should have 2+ years experience in clinical trials. Experience in supporting global clinical trials is an asset.
. Excellent interpersonal skills and ability to communicate effectively. Fluency in English, verbal and written, is essential.
. Good project management skills. Ability to engage in clinical, regulatory, scientific programming, and database management groups locally and internationally.
Senior Scientific Programmer / Statistical Programming Analyst
Responsibilities include:
. Documentation of programming requirements specifications based on Protocol, Study Analysis Plans and interactions with local and international stakeholders within the Statistics, Clinical and Regulatory groups.
. High quality SAS code development and validation.
. Among other stakeholders, contribution to the review of project specific data collection, data transfer and database specifications.
. Coordination of the project team activities in order to produce all safety and efficacy reporting deliverables (CDISC SDTM & ADaM files, clinical study report tables, listings and figures).
. Compliance to Standard Operating Procedures and Software Life Cycle.
Qualification:
. Master degree in Statistics, Life Sciences or related field.
. Several years of relevant experience involving statistical programming in the clinical trials environment. Exposure to global clinical trials is an asset.
. Requires thorough knowledge of programming techniques (especially very strong SAS skills – including macro language) and analytical ability.
. Good project management skills. Ability to engage key stakeholders in Statistics, Clinical and Regulatory groups locally and internationally (e.g. US, Japan, Europe).
. Broad knowledge of clinical trials processes.
. Excellent interpersonal skills and ability to communicate effectively. Excellent collaboration, negotiation and organization skills.
. Fluency in English, verbal and written, is essential.
In return for such skills and commitment, MacroStat offers a competitive salary package and fringe benefits as well as flexible working arrangements and potential career development opportunities.
作者：MacroStat(China) 在 生化制药 发贴, 来自【海归网】 http://www.haiguinet.com
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 Biostatistician/Senior Scientific Programmer -- MacroStat(China) - (3740 Byte) 2011-10-10 周一, 10:20 (1739 reads)
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